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

NCT ID: NCT00362375

Last Updated: 2010-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 313 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-04-30

Brief Summary

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.

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.

Conditions

HIV Infections; Sexually Transmitted Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Love Workshop

Single-session, small-group HIV prevention intervention

Group Type: EXPERIMENTAL

Healthy Love Workshop

Intervention Type: BEHAVIORAL

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.

HIV101

Single-session, small-group intervention providing facts regarding HIV/AIDS

Group Type: ACTIVE_COMPARATOR

HIV/AIDS 101 Workshop

Intervention Type: BEHAVIORAL

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.

Interventions

Healthy Love Workshop

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.

Intervention Type: BEHAVIORAL

HIV/AIDS 101 Workshop

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Healthy Love Party; Healthy Love; HIV101

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

SisterLove, Inc.

OTHER_GOV

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

SisterLove, Inc.

Principal Investigators

Dazon Dixon Diallo, MPH

Role: PRINCIPAL_INVESTIGATOR

President/CEO SisterLove, Inc.

Jeffrey H Herbst, PhD

Role: STUDY_DIRECTOR

Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC

Thomas M Painter, PhD

Role: STUDY_DIRECTOR

Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC

Locations

SisterLove, Inc.

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20135214 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24743662 (View on PubMed)

Related Links

http://www.sisterlove.org

SisterLove, Inc.

Other Identifiers

U65/CCU424514-02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDC-NCHSTP-1927-4768

Identifier Type: -

Identifier Source: org_study_id