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HIV/STI Prevention for Drug-Involved Couples (ConnectII)

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ClinicalTrials.gov Identifier: NCT01285349
Recruitment Status : Completed
First Posted : January 28, 2011
Results First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Louisa Gilbert, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Sexually Transmitted Infections
Interventions Behavioral: Couple HIV/STI prevention intervention
Behavioral: Couple-based HIV/STI prevention
Behavioral: Individual HIV/STI prevention
Behavioral: Couple Wellness Promotion
Enrollment 564
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Couple Wellness Promotion Couple-based HIV Prevention Individual HIV/STI Prevention
Hide Arm/Group Description

7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.

Couple Wellness Promotion :

7-session couple-based HIV/STI risk reduction intervention (CSTI)

Couple HIV/STI prevention intervention :

Couple-based HIV prevention :

7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.

Individual HIV/STI prevention :

Period Title: Overall Study
Started 190 190 184
Completed 163 170 157
Not Completed 27 20 27
Reason Not Completed
Lost to Follow-up             27             20             27
Arm/Group Title Couple Wellness Promotion Couple-based HIV Prevention Individual HIV/STI Prevention Total
Hide Arm/Group Description

7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.

Couple Wellness Promotion :

7-session couple-based HIV/STI risk reduction intervention (CSTI)

Couple HIV/STI prevention intervention :

Couple-based HIV prevention :

7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.

Individual HIV/STI prevention :

Total of all reporting groups
Overall Number of Baseline Participants 190 190 184 564
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 190 participants 184 participants 564 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
190
 100.0%
190
 100.0%
184
 100.0%
564
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: The participants in all 3 conditions provided behavioral and biological outcome data at baseline, immediate post-intervention, and at 6-month and 12-month postintervention time points. An audio computer–assisted self-interview (ACASI) was used to collect self-reported data on drug-related and sexual behavioral outcomes and sociodemographic variables.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants 190 participants 184 participants 564 participants
37.0  (6.8) 36.1  (7.4) 37.0  (7.2) 36.5  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 190 participants 184 participants 564 participants
Female
95
  50.0%
95
  50.0%
92
  50.0%
282
  50.0%
Male
95
  50.0%
95
  50.0%
92
  50.0%
282
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 190 participants 190 participants 184 participants 564 participants
190 190 184 564
1.Primary Outcome
Title Number of Unprotected Acts of Intercourse
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Couple-Based Wellness Promotion Couple-based HIV Prevention Individual HIV/STI Prevention
Hide Arm/Group Description:

7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.

Couple Wellness Promotion :

7-session couple-based HIV/STI risk reduction intervention (CSTI)

Couple HIV/STI prevention intervention :

Couple-based HIV prevention :

7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.

Individual HIV/STI prevention :

Overall Number of Participants Analyzed 163 170 163
Mean (Standard Deviation)
Unit of Measure: # of unprotected sex acts at 12 months
19.7  (28.1) 12.9  (19.2) 18.2  (27.0)
2.Secondary Outcome
Title Number of Participants With Biologically Confirmed STIs (i.e., Chlamydia, Gonorrhea, and Trichomoniasis)
Hide Description [Not Specified]
Time Frame past 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Couple Wellness Promotion Couple-based HIV Prevention Individual HIV/STI Prevention
Hide Arm/Group Description:

7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.

Couple Wellness Promotion :

7-session couple-based HIV/STI risk reduction intervention (CSTI)

Couple HIV/STI prevention intervention :

Couple-based HIV prevention :

7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.

Individual HIV/STI prevention :

Overall Number of Participants Analyzed 163 170 184
Measure Type: Number
Unit of Measure: participants
3 3 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Couple Wellness Promotion Couple-based HIV Prevention Individual HIV/STI Prevention
Hide Arm/Group Description

7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.

Couple Wellness Promotion :

7-session couple-based HIV/STI risk reduction intervention (CSTI)

Couple HIV/STI prevention intervention :

Couple-based HIV prevention :

7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.

Individual HIV/STI prevention :

All-Cause Mortality
Couple Wellness Promotion Couple-based HIV Prevention Individual HIV/STI Prevention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/190 (0.00%)   0/183 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Couple Wellness Promotion Couple-based HIV Prevention Individual HIV/STI Prevention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/190 (0.00%)   0/183 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Couple Wellness Promotion Couple-based HIV Prevention Individual HIV/STI Prevention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/190 (0.00%)   0/183 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Nabila El-Bassel
Organization: Social Intervention Group
Phone: 212-851-2391
Responsible Party: Louisa Gilbert, Columbia University
ClinicalTrials.gov Identifier: NCT01285349     History of Changes
Other Study ID Numbers: AAAA6653
First Submitted: January 21, 2011
First Posted: January 28, 2011
Results First Submitted: July 31, 2013
Results First Posted: January 14, 2019
Last Update Posted: January 14, 2019