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Social Media Based Peer-Led Intervention for HIV Prevention

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ClinicalTrials.gov Identifier: NCT03213366
Recruitment Status : Completed
First Posted : July 11, 2017
Results First Posted : September 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Albert Einstein College of Medicine
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Viraj V. Patel, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Conditions HIV Prevention
PrEP Uptake
Interventions Behavioral: E-PrEP- Peer-Led Intervention about PrEP
Behavioral: BxNow - General Health Campaign
Enrollment 152
Recruitment Details  
Pre-assignment Details  
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow-General Health Control Arm:
Hide Arm/Group Description

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Period Title: Overall Study
Number of participants Number of units (Peers) Number of participants Number of units (Peers)
Started 81 7 71 5
Completed 72 5 67 5
Not Completed 9 2 4 0
Reason Not Completed
Lost to Follow-up             9                         4            
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm Total
Hide Arm/Group Description

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.

 Total of all reporting groups
Overall Number of Baseline Participants 81 71 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 71 participants 152 participants
24.28  (2.83) 23.32  (3.39) 23.84  (2.83)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Gender Identity Number Analyzed 81 participants 71 participants 152 participants
Male
68
  84.0%
64
  90.1%
132
  86.8%
Female/Transfemale
7
   8.6%
3
   4.2%
10
   6.6%
Transmale
1
   1.2%
0
   0.0%
1
   0.7%
Gender Non-conforming/Gender Non-Binary
2
   2.5%
0
   0.0%
2
   1.3%
Queer
3
   3.7%
4
   5.6%
7
   4.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 81 participants 71 participants 152 participants
Latinx/Hispanic
26
  32.1%
47
  66.2%
73
  48.0%
Non-Hispanic Black
55
  67.9%
24
  33.8%
79
  52.0%
Residence  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 71 participants 152 participants
Bronx
44
  54.3%
35
  49.3%
79
  52.0%
Brooklyn
18
  22.2%
14
  19.7%
32
  21.1%
Manhattan
16
  19.8%
13
  18.3%
29
  19.1%
Queens
2
   2.5%
8
  11.3%
10
   6.6%
Staten Island
1
   1.2%
1
   1.4%
2
   1.3%
Sexual Identity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 71 participants 152 participants
Gay/Homosexual
60
  74.1%
56
  78.9%
116
  76.3%
Queer
12
  14.8%
3
   4.2%
15
   9.9%
Bisexual
7
   8.6%
10
  14.1%
17
  11.2%
Heterosexual/Straight
1
   1.2%
1
   1.4%
2
   1.3%
Other
1
   1.2%
1
   1.4%
2
   1.3%
Education Level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 71 participants 152 participants
High School or Less
36
  44.4%
27
  38.0%
63
  41.4%
Some College
28
  34.6%
35
  49.3%
63
  41.4%
College and Beyond
17
  21.0%
9
  12.7%
26
  17.1%
Employment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 81 participants 71 participants 152 participants
Full Time
24
  29.6%
29
  40.8%
53
  34.9%
Part Time
17
  21.0%
15
  21.1%
32
  21.1%
Unemployed
31
  38.3%
15
  21.1%
46
  30.3%
Disable
3
   3.7%
2
   2.8%
5
   3.3%
Student
12
  14.8%
13
  18.3%
25
  16.4%
[1]
Measure Description: Participants had the option to select more than one answer in order to best describe their employment status (not mutually exclusive).
Income  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 71 participants 152 participants
None
12
  14.8%
14
  19.7%
26
  17.1%
Less than $10,000
26
  32.1%
15
  21.1%
41
  27.0%
$10,000-$19,999
11
  13.6%
10
  14.1%
21
  13.8%
$20,000-$29,999
13
  16.0%
6
   8.5%
19
  12.5%
$30,000-$39,999
11
  13.6%
16
  22.5%
27
  17.8%
$40,000-more
8
   9.9%
10
  14.1%
18
  11.8%
Living Situation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 71 participants 152 participants
Don't have a place to live
4
   4.9%
2
   2.8%
6
   3.9%
Temporary Living Situation
15
  18.5%
7
   9.9%
22
  14.5%
Parents/Family
29
  35.8%
36
  50.7%
65
  42.8%
Partner/Boyfriend/Husband
2
   2.5%
7
   9.9%
9
   5.9%
Roomates
20
  24.7%
14
  19.7%
34
  22.4%
Alone
11
  13.6%
4
   5.6%
15
   9.9%
Wife/Females Partner/Girlfriend
0
   0.0%
1
   1.4%
1
   0.7%
Health Insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 71 participants 152 participants
Yes
61
  75.3%
59
  83.1%
120
  78.9%
No
18
  22.2%
10
  14.1%
28
  18.4%
I don't kno
2
   2.5%
2
   2.8%
4
   2.6%
1.Primary Outcome
Title Number of Participants Intending to Start Using PrEP Over Time
Hide Description

This primary outcome is intention to use PrEP in the next month measured at baseline, 6 weeks, and 12 weeks. This was assessed with a yes/no question (dichotomous variable). However, this variable does not include anyone who reported PrEP use at either 6 or 12 weeks.

This outcome will inform sample size calculations for a subsequent fully powered trial.
Time Frame baseline, 6 weeks, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Each of the rows indicates the number of participants who indicated intending to use PrEP at each time point (Baseline vs. 6 weeks vs. 12 weeks).
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 65 63
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Yes
32
  49.2%
34
  54.0%
No
33
  50.8%
29
  46.0%
6 Weeks Yes
23
  35.4%
27
  42.9%
No
42
  64.6%
36
  57.1%
12 Weeks Yes
27
  41.5%
32
  50.8%
No
38
  58.5%
31
  49.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 6 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5783
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.0095
Confidence Interval (2-Sided) 95%
-0.04676 to 0.02776
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 12 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3185
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.01692
Confidence Interval (2-Sided) 95%
-0.05318 to 0.01933
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Using PrEP Over Time
Hide Description This outcome is the number of participants who self-report using PrEP at baseline, 6 weeks, or 12 weeks. This was measure by a yes/no question asking if the participant currently uses PrEP (dichotomous variable).
Time Frame at baseline, 6 weeks, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 65 63
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Yes
13
  20.0%
11
  17.5%
No
52
  80.0%
52
  82.5%
6 weeks Yes
17
  26.2%
11
  17.5%
No
48
  73.8%
52
  82.5%
12 weeks Yes
14
  21.5%
13
  20.6%
No
51
  78.5%
50
  79.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 6 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07863
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.03674
Confidence Interval (2-Sided) 95%
-0.00516 to 0.07863
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 12 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1999
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.02594
Confidence Interval (2-Sided) 95%
-0.01648 to 0.06836
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in PrEP Knowledge
Hide Description

Self-reported PrEP related knowledge.

Participants were asked two questions about PrEP knowledge. For each question, they got one point if the answer was correct.

Scale range from 0-2. The score were added and the average of the sum was reported.

The higher the score, the higher the knowledge of PrEP.
Time Frame at baseline, 6 weeks, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 65 63
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.86  (0.43) 1.7  (0.59)
6 Weeks 1.86  (0.39) 1.83  (0.46)
12 Weeks 1.83  (0.49) 1.73  (0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 6 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8963
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.000443
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 12 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3229
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.004308
Estimation Comments [Not Specified]
4.Secondary Outcome
Title PrEP Awareness
Hide Description

Awareness about PrEP.

PrEP awareness was measured with one question, scored 1 to 5. The mean for each arm was calculated at each time point.

The higher the score, the higher the level of awareness about PrEP.
Time Frame baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
T
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 65 63
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 4.14  (0.95) 4.02  (0.88)
6 Weeks 4.29  (0.96) 4.13  (0.91)
12 Weeks 4.52  (0.69) 4.19  (0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2433
Comments This t-test was for the random effects model not for comparing the difference between the arms.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.008705
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 12 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0839
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.01358
Estimation Comments [Not Specified]
5.Secondary Outcome
Title PrEP Stigma
Hide Description

Any stigma the participant might have about PrEP or those who use PrEP

To measure PrEP Stigma we asked 3 questions, using a Likert scale (from 1-4; 1= Strongly Disagree, 4=Strongly Agree). The scores were summed for each participant. The scores range from 1-12, with higher scores indicating higher levels of PrEP Stigma.

The higher the score, the higher the level of PrEP stigma.
Time Frame baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 69 63
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 6.25  (2.21) 6.78  (2.39)
6 Weeks 5.40  (2.55) 6.24  (2.87)
12 Weeks 5.12  (2.34) 6.0  (2.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 6 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2114
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.302
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 12 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2141
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.03149
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Communication About PrEP
Hide Description

Discussion of PrEP with friends, partners, or family. Communication about PrEP was measured with 2 questions, using a Likert scale ( from 1-5;1=Not at all, 5= Extremely). The scores of the 2 questions were summed for each participant.

The scores range from 1-10, with higher the score indicating higher the level of communication about PrEP (i.e. higher scores indicates participants communicating more about PrEP).
Time Frame baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 65 63
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 8.42  (2.38) 8.24  (2.29)
6 Weeks 9.14  (1.47) 8.60  (1.85)
12 Weeks 8.94  (1.81) 8.32  (2.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 6 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0124
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.0278
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 12 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.03052
Estimation Comments [Not Specified]
7.Secondary Outcome
Title PrEP Barriers
Hide Description

Any Barriers to PrEP uptake.

To measure barriers to PrEP uptake, 7 items were used. Each item was measured using a likert scale ( from 1-4; 1=Strongly Disagree, 4= Strongly Agree). The scores of each question were summed for each participant (scale scores ranged 1-28, with higher scores indicating higher levels of PrEP Barriers).

The higher the score, the higher the number of PrEP Barriers.
Time Frame baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 65 63
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 17.80  (4.28) 18.73  (4.6)
6 Weeks 17.11  (5.17) 18.76  (5.22)
12 Weeks 16.55  (4.92) 17.84  (5.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 6 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1021
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.05747
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 12 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.05101
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Self-efficacy About Using PrEP
Hide Description Self-reported answer to questions about self-efficacy of using PrEP. There were two questions to measure self-efficacy of PrEP using a Likert scale (ranging from 1-5; 1=Not at all, 5=Extremely). The scores from both questions were summed for each participant. The scale range from 1-10 with higher scores indicating higher the levels of PrEP self-efficacy.
Time Frame at baseline, 6 weeks, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 65 63
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 8.26  (2.39) 8.19  (2.35)
6 Weeks 8.88  (1.72) 8.49  (1.86)
12 Weeks 8.75  (1.97) 8.13  (2.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 6 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0818
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.0209
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E-PrEP- Peer-Led Intervention About PrEP, BxNow- General Health Control Arm
Comments At 12 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0334
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.03103
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Number of Participants With Self-reported HIV Testing
Hide Description Self-reported HIV testing at baseline, 6 weeks, and 12 weeks.
Time Frame at baseline, 6 weeks, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Each row indicates when the participant who responded to the survey at baseline, 6 weeks, and 12 weeks.
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 81 71
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 81 participants 71 participants
1 month
33
  40.7%
22
  31.0%
3 months or less
29
  35.8%
20
  28.2%
4 to 6 months
10
  12.3%
16
  22.5%
7 to 12 months
6
   7.4%
7
   9.9%
More than 12 months
1
   1.2%
2
   2.8%
I have never been tested for STI
2
   2.5%
4
   5.6%
6 Weeks Number Analyzed 69 participants 66 participants
1 month
24
  34.8%
20
  30.3%
3 months or less
26
  37.7%
23
  34.8%
4 to 6 months
11
  15.9%
13
  19.7%
7 to 12 months
1
   1.4%
6
   9.1%
More than 12 months
5
   7.2%
3
   4.5%
I have never been tested for STI
2
   2.9%
1
   1.5%
12 Weeks Number Analyzed 71 participants 65 participants
1 month
26
  36.6%
18
  27.7%
3 months or less
31
  43.7%
19
  29.2%
4 to 6 months
9
  12.7%
15
  23.1%
7 to 12 months
0
   0.0%
7
  10.8%
More than 12 months
4
   5.6%
3
   4.6%
I have never been tested for STI
1
   1.4%
3
   4.6%
10.Other Pre-specified Outcome
Title Number of Participants With Self-reported Linkage-to-Care
Hide Description Self-reported information about health care access (i.e. going to a medical appointment).
Time Frame at baseline, 6 weeks, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Each row has the number of participants who access healthcare at each time point in the "yes" category, and the number of people who did not access healthcare in the "no" category. (Baseline vs. 6 weeks vs. 12 weeks).
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 81 71
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline- Visit in the past 12 months Number Analyzed 81 participants 71 participants
Yes
61
  75.3%
64
  90.1%
No
20
  24.7%
7
   9.9%
6 Weeks- Visit in the past 6 weeks Number Analyzed 69 participants 66 participants
Yes
40
  58.0%
41
  62.1%
No
29
  42.0%
25
  37.9%
12 Weeks- Visit in the past 12 weeks Number Analyzed 71 participants 65 participants
Yes
45
  63.4%
33
  50.8%
No
26
  36.6%
32
  49.2%
11.Other Pre-specified Outcome
Title Trust in the Peer by Participant
Hide Description

The scale measure the level of trust the Participant had on the Peer's online post.

Trust in the Peer Leader was measured using 4 questions, each scored from 1-7 (1=Strongly Disagree, 7=Strongly Agree). The score for the 4 questions was summed for each participant. The score ranged from 1-28 with higher scores indicating a higher level of trust the participant had in their Peer Leader.
Time Frame at baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The total number of participants who completed baseline study was 81 for e-prep and 71 for control. The analysis for 6 weeks included only the people who completed the survey at each that time period.
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow- General Health Control Arm
Hide Arm/Group Description:

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.

We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.

Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.
Overall Number of Participants Analyzed 81 71
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 81 participants 71 participants
16.4  (4.15) 14.32  (4.27)
6 Weeks Number Analyzed 69 participants 66 participants
16.06  (4.48) 15.71  (4.28)
Time Frame Adverse events were tracked for a period of 12 weeks.
Adverse Event Reporting Description There was no risk for serious or adverse events. All of the the risk were minimal. None of the participants were at risk of mortality.
 
Arm/Group Title E-PrEP- Peer-Led Intervention About PrEP BxNow - General Health Campaign
Hide Arm/Group Description

8 Peer Leaders (PLs) will be randomly assigned to the E-PrEP arm. Each of the PLs will recruit at least 15 participants into a private social media group on one of several social media platforms. PLs will then deliver a behavioral intervention over a 6 week period, posting information and engaging participants in a discussion about PrEP, PrEP access, and other related health issues. All contents will be formatted to be both mobile device accessible.

Intervention contents and targets were informed by a systematic review of PrEP barriers and facilitators, a locally conducted qualitative study, and key informant and peer leader inputs. The contents were developed or adapted by study staff and peer leaders. Components and associated text have been designed to engage participants in online discussions about PrEP and related health and social topics. Posts will also include information about linkage-to-care, and insurance access. New contents will be posted almost daily.

BxNow is an attention-matched control. Eight of the 16 PLs will be randomly assigned to the BxNow arm. The BxNow campaign will be a 6-week long social media intervention about general health wellness topics chosen and administered by the PLs assigned into this arm. Similarly to the intervention group, PLs in the BxNow arm will create private social media groups and recruit participants into these private groups. General health information in the BxNow arm will be posted with the same frequency as in the intervention arm.

BxNow - General Health Campaign: BxNow will focus on general health topics unrelated to HIV or sexual health (i.e. fitness, nutrition, smoking), as chosen by PLs. Contents will be developed or adapted by PLs and posted almost daily. Posts will also include information about linkage-to-care and insurance access. At the end of the intervention, BxNow participants will be exposed to E-PrEP components at the end of the trial.
All-Cause Mortality
E-PrEP- Peer-Led Intervention About PrEP BxNow - General Health Campaign
Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)   0/71 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
E-PrEP- Peer-Led Intervention About PrEP BxNow - General Health Campaign
Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)   0/71 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
E-PrEP- Peer-Led Intervention About PrEP BxNow - General Health Campaign
Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)   0/71 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Viraj V Patel
Organization: Albert Einstein College of Medicine
Phone: 718.920-7102
EMail: vpatel@montefiore.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Viraj V. Patel, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03213366     History of Changes
Other Study ID Numbers: 2016-7263
5K23MH102118-04 ( U.S. NIH Grant/Contract )
First Submitted: March 28, 2017
First Posted: July 11, 2017
Results First Submitted: April 25, 2019
Results First Posted: September 6, 2019
Last Update Posted: November 6, 2019