- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00362375
Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women
Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women by SisterLove, Inc. in Atlanta, GA
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SisterLove, Inc. in Atlanta, Georgia, is evaluating its HIV/AIDS prevention intervention called the Healthy Love Workshop (HLW). The HLW targets African American women and women of African descent who are at risk for HIV infection and transmission. The HLW, which lasts 3 to 4 hours and is delivered during a single session, is a highly interactive workshop that aims to provide a safe environment in which women can learn about: a) the modes of HIV transmission, b) effective strategies for reducing one's risk for contracting or transmitting HIV or other STIs, c) opportunities to develop or enhance skills for self-assessing the risk level of sexual behaviors and the use of safer sex techniques, and d) how to develop an awareness of personal, community and social attitudes, beliefs and norms that influence women's relationships, sexual behavior, and decision-making. SisterLove will identify a minimum of 28 groups of women to participate in the evaluation, which will use a concurrent comparison design with block randomization. These groups will be typical of those that currently receive the HLW, including but not limited to sororities, friendship circles, church groups and other affinity-based groups. Fourteen of the 28 groups will participate in HLW as the intervention group; 14 of the recruited groups will participate in an HIV/AIDS 101 workshop (HIV 101) as the comparison group. Each group will contain about 15 women, thus approximately 420 women will participate in the evaluation. Outcome measures will assess HIV/AIDS knowledge, attitudes towards condom use and HIV testing, condom use intentions, personal HIV/AIDS risk assessment, self-efficacy for taking steps to prevent HIV transmission, consistent condom use, sexual abstinence, and reduction in other sexual risk behaviors. These outcomes will be measured at baseline, and after the intervention at 3- and 6-month follow-ups.
Eligible groups of women were randomly assigned to receive the intervention (15 groups; 161 women) or a comparison workshop (15 groups; 152 women). Behavioral assessments were conducted at baseline and at 3- and 6-month follow-ups. Among sexually active women at the 3-month follow-up, HLW participants were more likely than comparison participants to report having used condoms during vaginal sex with any male partner or with a primary male partner, and to have used condoms at last vaginal, anal or oral sex with any male partner. At the 6-month follow-up, HLW participants were more likely to report condom use at last vaginal, anal or oral sex with any male partner, and having an HIV test and receiving their test results. The study findings suggest that a single-session intervention delivered to pre-existing groups of black women is an efficacious approach to HIV prevention. This study also demonstrates that a CBO can develop and deliver a culturally appropriate, effective HIV prevention intervention for the population it serves and, with adequate resources and technical assistance, rigorously evaluate its intervention.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30331
- SisterLove, Inc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women of African descent (including African Americans, Caribbean, and African Immigrants)
- Over the age of 18 years
Exclusion Criteria:
- Women who are pregnant or planning to become pregnant
- Do not speak English
- Recent (past 6 months) participation in HIV prevention workshop
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Love Workshop
Single-session, small-group HIV prevention intervention
|
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.
Other Names:
|
Active Comparator: HIV101
Single-session, small-group intervention providing facts regarding HIV/AIDS
|
The comparison workshop (named HIV101) was also delivered as a single session lasting 2-3 h, to groups of women about the same size and in settings similar to those used for the HLW.
The HIV101 workshop consists of an opening, one module containing the same three HIV/STD-related components as the HLW (HIV/AIDS facts, STI facts, and the Look of HIV) and a closing.
However, the presentation of this information used a didactic, lecture-style format, as opposed to the interactive approach used to deliver the HLW.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Condom Use During Vaginal Sex With Any Male Partner
Time Frame: Past 3 months
|
Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months
|
Past 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Testing and Receipt of Results
Time Frame: Past 3 months
|
Percentage of women who reported testing for HIV infection and received their test results during the past 3 months
|
Past 3 months
|
HIV Knowledge
Time Frame: current
|
current
|
|
Condom Use Self-efficacy
Time Frame: current
|
current
|
|
Knowledge of HIV Test
Time Frame: current
|
current
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Abstinence
Time Frame: Past 3 months
|
The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners
|
Past 3 months
|
Unprotected Vaginal Sex With Any Male Partner
Time Frame: Past 3 months
|
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
|
Past 3 months
|
Number of Male Sex Partners
Time Frame: Past 3 months
|
The number of male sex partners during the past 3 months
|
Past 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dazon Dixon Diallo, MPH, President/CEO SisterLove, Inc.
- Study Director: Jeffrey H Herbst, PhD, Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
- Study Director: Thomas M Painter, PhD, Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
Publications and helpful links
General Publications
- Diallo DD, Moore TW, Ngalame PM, White LD, Herbst JH, Painter TM. Efficacy of a single-session HIV prevention intervention for black women: a group randomized controlled trial. AIDS Behav. 2010 Jun;14(3):518-29. doi: 10.1007/s10461-010-9672-5.
- Painter TM, Herbst JH, Diallo DD, White LD; Centers for Disease Control and Prevention (CDC). Community-based program to prevent HIV/STD infection among heterosexual black women. MMWR Suppl. 2014 Apr 18;63(1):15-20.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- HIV Infections
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases
Other Study ID Numbers
- CDC-NCHSTP-1927-4768
- U65/CCU424514-02 (Other Grant/Funding Number: CDC Cooperative Agreement U65/CCU424514)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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