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Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women

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ClinicalTrials.gov Identifier: NCT00362375
Recruitment Status : Completed
First Posted : August 10, 2006
Results First Posted : May 14, 2010
Last Update Posted : May 14, 2010
Sponsor:
Collaborator:
SisterLove, Inc.
Information provided by:
Centers for Disease Control and Prevention

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV Infections
Sexually Transmitted Infections
Interventions Behavioral: Healthy Love Workshop
Behavioral: HIV/AIDS 101 Workshop
Enrollment 313
Recruitment Details Information about the study was disseminated through print media, public service announcements on local radio stations, electronic communication and informational mailings to local AIDS service organizations, county health departments, medical clinics, and community centers.
Pre-assignment Details 28 groups did not participate for logistical reasons, including lack of follow-up by group contact (10 groups), failure of women to arrive for the workshop (7 groups), and too few women to meet minimum workshop size (6 groups). Five groups did not participate because of insufficient interest by their members in receiving either workshop.
Arm/Group Title Healthy Love Workshop HIV101
Hide Arm/Group Description The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results. The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
Period Title: Overall Study
Started 161 [1] 152 [1]
Completed 121 [2] 117 [2]
Not Completed 40 35
Reason Not Completed
Lost to Follow-up             40             35
[1]
Number eligible and randomized
[2]
Number completed 6-month follow-up assessment
Arm/Group Title Healthy Love Workshop HIV101 Total
Hide Arm/Group Description The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results. The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections. Total of all reporting groups
Overall Number of Baseline Participants 161 152 313
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 152 participants 313 participants
29.1  (10.1) 33.7  (12.7) 31.3  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 152 participants 313 participants
Female
161
 100.0%
152
 100.0%
313
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 161 participants 152 participants 313 participants
161 152 313
1.Primary Outcome
Title Condom Use During Vaginal Sex With Any Male Partner
Hide Description Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months
Time Frame Past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Women who were sexually active at 3-month follow-up and who provided data on outcome measure
Arm/Group Title Healthy Love Workshop HIV101
Hide Arm/Group Description:
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
Overall Number of Participants Analyzed 93 94
Measure Type: Number
Unit of Measure: Percent
59.3 39.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV101
Comments GEE cluster-adjusted odds ratio
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.40
Confidence Interval (2-Sided) 95%
1.28 to 4.50
Estimation Comments [Not Specified]
2.Secondary Outcome
Title HIV Testing and Receipt of Results
Hide Description Percentage of women who reported testing for HIV infection and received their test results during the past 3 months
Time Frame Past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on the number of women who provided data at the 3-month follow-up
Arm/Group Title Healthy Love Workshop HIV101
Hide Arm/Group Description:
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
Overall Number of Participants Analyzed 116 116
Measure Type: Number
Unit of Measure: Percent
20.2 16.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV101
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
0.76 to 2.71
Estimation Comments [Not Specified]
3.Secondary Outcome
Title HIV Knowledge
Hide Description [Not Specified]
Time Frame current
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Condom Use Self-efficacy
Hide Description [Not Specified]
Time Frame current
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Knowledge of HIV Test
Hide Description [Not Specified]
Time Frame current
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Sexual Abstinence
Hide Description The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners
Time Frame Past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on the number of women who provided valid data at the 3-month follow-up
Arm/Group Title Healthy Love Workshop HIV101
Hide Arm/Group Description:
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
Overall Number of Participants Analyzed 93 94
Measure Type: Number
Unit of Measure: Percent
36.6 43.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV101
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.20 to 1.16
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Unprotected Vaginal Sex With Any Male Partner
Hide Description The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months
Time Frame Past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on the number of women who provided valid data at the 3-month follow-up
Arm/Group Title Healthy Love Workshop HIV101
Hide Arm/Group Description:
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
Overall Number of Participants Analyzed 93 94
Measure Type: Number
Unit of Measure: Percent
37.6 36.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV101
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
0.99 to 1.95
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Number of Male Sex Partners
Hide Description The number of male sex partners during the past 3 months
Time Frame Past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on the number of women who provided valid data at the 3-month follow-up
Arm/Group Title Healthy Love Workshop HIV101
Hide Arm/Group Description:
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
Overall Number of Participants Analyzed 93 94
Mean (Standard Deviation)
Unit of Measure: Number of sex partners
0.70  (0.60) 0.67  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV101
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method GEE
Comments GEE incident rate ratio
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.80 to 1.44
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Love Workshop HIV101
Hide Arm/Group Description The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results. The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
All-Cause Mortality
Healthy Love Workshop HIV101
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Love Workshop HIV101
Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)   0/152 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Love Workshop HIV101
Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)   0/152 (0.00%) 
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
Name/Title: Dazon Dixon-Diallo, Executive Director
Organization: SisterLove, Inc.
Phone: 404-505-7777
Responsible Party: Dazon Dixon Diallo, MPH, CEO, SisterLove, Inc.
ClinicalTrials.gov Identifier: NCT00362375     History of Changes
Other Study ID Numbers: CDC-NCHSTP-1927-4768
U65/CCU424514-02 ( Other Grant/Funding Number: CDC Cooperative Agreement U65/CCU424514 )
First Submitted: August 8, 2006
First Posted: August 10, 2006
Results First Submitted: March 8, 2010
Results First Posted: May 14, 2010
Last Update Posted: May 14, 2010