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

Primary Purpose

HIV Infections, Sexually Transmitted Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Healthy Love Workshop
HIV/AIDS 101 Workshop
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Adult, *HIV Infections/pc [Prevention & Control], Female, Humans, Risk-Taking, Safe Sex, Sexual Behavior, HIV Testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • SisterLove, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthy Love Workshop

HIV101

Arm Description

Single-session, small-group HIV prevention intervention

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

Outcomes

Primary Outcome Measures

Condom Use During Vaginal Sex With Any Male Partner
Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months

Secondary Outcome Measures

HIV Testing and Receipt of Results
Percentage of women who reported testing for HIV infection and received their test results during the past 3 months
HIV Knowledge
Condom Use Self-efficacy
Knowledge of HIV Test

Full Information

First Posted
August 8, 2006
Last Updated
April 27, 2010
Sponsor
Centers for Disease Control and Prevention
Collaborators
SisterLove, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00362375
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
SisterLove, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Infections
Keywords
Adult, *HIV Infections/pc [Prevention & Control], Female, Humans, Risk-Taking, Safe Sex, Sexual Behavior, HIV Testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Love Workshop
Arm Type
Experimental
Arm Description
Single-session, small-group HIV prevention intervention
Arm Title
HIV101
Arm Type
Active Comparator
Arm Description
Single-session, small-group intervention providing facts regarding HIV/AIDS
Intervention Type
Behavioral
Intervention Name(s)
Healthy Love Workshop
Other Intervention Name(s)
Healthy Love Party, Healthy Love
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
HIV/AIDS 101 Workshop
Other Intervention Name(s)
HIV101
Intervention Description
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.
Primary Outcome Measure Information:
Title
Condom Use During Vaginal Sex With Any Male Partner
Description
Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months
Time Frame
Past 3 months
Secondary Outcome Measure Information:
Title
HIV Testing and Receipt of Results
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
Title
HIV Knowledge
Time Frame
current
Title
Condom Use Self-efficacy
Time Frame
current
Title
Knowledge of HIV Test
Time Frame
current
Other Pre-specified Outcome Measures:
Title
Sexual Abstinence
Description
The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners
Time Frame
Past 3 months
Title
Unprotected Vaginal Sex With Any Male Partner
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
Title
Number of Male Sex Partners
Description
The number of male sex partners during the past 3 months
Time Frame
Past 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dazon Dixon Diallo, MPH
Organizational Affiliation
President/CEO SisterLove, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey H Herbst, PhD
Organizational Affiliation
Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas M Painter, PhD
Organizational Affiliation
Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
Official's Role
Study Director
Facility Information:
Facility Name
SisterLove, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20135214
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.
Results Reference
result
PubMed Identifier
24743662
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.
Results Reference
derived
Links:
URL
http://www.sisterlove.org
Description
SisterLove, Inc.

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

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