Clinical trial NCT00362375: Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women
Official title: Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women by SisterLove, Inc. in Atlanta, GA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Sexually Transmitted Infections
Keywords: Adult
*HIV Infections/pc [Prevention & Control]
Female
Humans
Risk-Taking
Safe Sex
Sexual Behavior
HIV Testing
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: SisterLove, Inc.
First posted: 2006-08-10
Enrollment: 313
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Condom Use During Vaginal Sex With Any Male Partner
timeFrame: Past 3 months
Secondary outcomes:
measure: HIV Testing and Receipt of Results
timeFrame: Past 3 months
measure: HIV Knowledge
timeFrame: current
measure: Condom Use Self-efficacy
timeFrame: current
measure: Knowledge of HIV Test
timeFrame: current
Other outcomes:
measure: Sexual Abstinence
timeFrame: Past 3 months
measure: Unprotected Vaginal Sex With Any Male Partner
timeFrame: Past 3 months
measure: Number of Male Sex Partners
timeFrame: Past 3 months
Locations:
city: Atlanta
country: United States
facility: SisterLove, Inc.
state: Georgia
Study officials:
affiliation: President/CEO SisterLove, Inc.
name: Dazon Dixon Diallo, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
name: Jeffrey H Herbst, PhD
role: STUDY_DIRECTOR
affiliation: Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
name: Thomas M Painter, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.