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

The purpose of this program evaluation is to determine whether the Health Love Workshop, a group-level HIV behavioral intervention, reduces HIV-related sex risk behaviors and increases HIV protective behaviors of African American women and women of African descent. The intent of this program is to support an evaluation of the efficacy of the intervention and to provide feedback to the implementing organization to increase intervention effectiveness.

Study Overview

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

Interventional

Enrollment (Actual)

313

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30331
        • SisterLove, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Healthy Love Party
  • Healthy Love
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:
  • HIV101

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (Estimate)

August 10, 2006

Study Record Updates

Last Update Posted (Estimate)

May 14, 2010

Last Update Submitted That Met QC Criteria

April 27, 2010

Last Verified

April 1, 2010

More Information

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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