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

This study has been completed.
Sponsor:
Collaborator:
SisterLove, Inc.
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00362375
First received: August 8, 2006
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
HIV Infections
Sexually Transmitted Infections
Behavioral: Healthy Love Workshop
Behavioral: HIV/AIDS 101 Workshop
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women by SisterLove, Inc. in Atlanta, GA

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Condom Use During Vaginal Sex With Any Male Partner [ Time Frame: Past 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Past 3 months ] [ Designated as safety issue: No ]
    Percentage of women who reported testing for HIV infection and received their test results during the past 3 months

  • HIV Knowledge [ Time Frame: current ] [ Designated as safety issue: No ]
  • Condom Use Self-efficacy [ Time Frame: current ] [ Designated as safety issue: No ]
  • Knowledge of HIV Test [ Time Frame: current ] [ Designated as safety issue: No ]

Enrollment: 313
Study Start Date: May 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Love Workshop
Single-session, small-group HIV prevention intervention
Behavioral: 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.
Other Names:
  • Healthy Love Party
  • Healthy Love
Active Comparator: HIV101
Single-session, small-group intervention providing facts regarding HIV/AIDS
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.
Other Name: HIV101

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362375

Locations
United States, Georgia
SisterLove, Inc.
Atlanta, Georgia, United States, 30331
Sponsors and Collaborators
SisterLove, Inc.
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dazon Dixon Diallo, MPH, CEO, SisterLove, Inc.
ClinicalTrials.gov Identifier: NCT00362375     History of Changes
Other Study ID Numbers: CDC-NCHSTP-1927-4768, U65/CCU424514-02
Study First Received: August 8, 2006
Results First Received: March 8, 2010
Last Updated: April 27, 2010
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Adult
*HIV Infections/pc [Prevention & Control]
Female
Humans
Risk-Taking
Safe Sex
Sexual Behavior
HIV Testing

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Genital Diseases, Female
Immunologic Deficiency Syndromes
Communicable Diseases
Infection
Sexually Transmitted Diseases
Genital Diseases, Male
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014