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Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women
This study is ongoing, but not recruiting participants.
First Received: August 8, 2006   Last Updated: April 17, 2007   History of Changes
Sponsors and Collaborators: Centers for Disease Control and Prevention
SisterLove, Inc.
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00362375
  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 I
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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:
  • 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

Secondary Outcome Measures:
  • HIV testing behaviors
  • Receipt of HIV test results
  • Communication of HIV test results to spouse or other sex partners

Estimated Enrollment: 420
Study Start Date: May 2006
Estimated Study Completion Date: June 2007
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.

  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
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.
Investigator: Jeffrey H Herbst, PhD Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
Investigator: Thomas M Painter, PhD Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
  More Information

No publications provided

Study ID Numbers: CDC-NCHSTP-1927-4768, U65/CCU424514-02
Study First Received: August 8, 2006
Last Updated: April 17, 2007
ClinicalTrials.gov Identifier: NCT00362375     History of Changes
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

Study placed in the following topic categories:
Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Antibodies
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Healthy
Genital Diseases, Male
Retroviridae Infections
Immunologic Deficiency Syndromes

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

ClinicalTrials.gov processed this record on September 02, 2009