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Sponsors and Collaborators: |
Centers for Disease Control and Prevention SisterLove, Inc. |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00362375 |
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 |
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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 |
Estimated Enrollment: | 420 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | June 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
SisterLove, Inc. | |
Atlanta, Georgia, United States, 30331 |
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 |
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 |
Adult *HIV Infections/pc [Prevention & Control] Female Humans |
Risk-Taking Safe Sex Sexual Behavior HIV Testing |
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 |
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 |