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

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ClinicalTrials.gov Identifier: NCT00362375
Recruitment Status : Completed
First Posted : August 10, 2006
Results First Posted : May 14, 2010
Last Update Posted : May 14, 2010
Sponsor:
Collaborator:
SisterLove, Inc.
Information provided by:
Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE August 8, 2006
First Posted Date  ICMJE August 10, 2006
Results First Submitted Date  ICMJE March 8, 2010
Results First Posted Date  ICMJE May 14, 2010
Last Update Posted Date May 14, 2010
Study Start Date  ICMJE May 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2006)
  • Consistent condom use
  • sexual abstinence
  • sexual risk behaviors such as unprotected vaginal, anal, and oral sex with main or casual partners
  • having sex while under the influence of drugs and alcohol
  • number of sex partners
  • HIV knowledge
  • attitudes towards condom use
  • condom use intentions
  • reasons for taking an HIV test
  • ability to assess personal HIV/AIDS risk
  • condom use self-efficacy
Change History Complete list of historical versions of study NCT00362375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2010)
  • 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
  • HIV Knowledge [ Time Frame: current ]
  • Condom Use Self-efficacy [ Time Frame: current ]
  • Knowledge of HIV Test [ Time Frame: current ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2006)
  • HIV testing behaviors
  • Receipt of HIV test results
  • Communication of HIV test results to spouse or other sex partners
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women
Official Title  ICMJE Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women by SisterLove, Inc. in Atlanta, GA
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Sexually Transmitted Infections
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Healthy Love Workshop
    Single-session, small-group HIV prevention intervention
    Intervention: Behavioral: Healthy Love Workshop
  • Active Comparator: HIV101
    Single-session, small-group intervention providing facts regarding HIV/AIDS
    Intervention: Behavioral: HIV/AIDS 101 Workshop
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2010)
313
Original Enrollment  ICMJE
 (submitted: August 8, 2006)
420
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00362375
Other Study ID Numbers  ICMJE CDC-NCHSTP-1927-4768
U65/CCU424514-02 ( Other Grant/Funding Number: CDC Cooperative Agreement U65/CCU424514 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dazon Dixon Diallo, MPH, CEO, SisterLove, Inc.
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE SisterLove, Inc.
Investigators  ICMJE
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
PRS Account Centers for Disease Control and Prevention
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP