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HIV InfectionsPhase 1/2NCT00362375

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

A Phase 1/2 study testing Healthy Love Workshop and HIV/AIDS 101 Workshop in people with HIV Infections and Sexually Transmitted Infections, run by Centers for Disease Control and Prevention at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Healthy Love Workshop and HIV/AIDS 101 Workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
313 participants
Where
1 siteUnited States
Study dates
May 2006to Apr 2008
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women of African descent (including African Americans, Caribbean, and African Immigrants)
  • Over the age of 18 years

Who cannot join

  • Women who are pregnant or planning to become pregnant
  • Do not speak English
  • Recent (past 6 months) participation in HIV prevention workshop

Trial locations and contacts

1 site in 1 country.

United States1 site
  • SisterLove, Inc.

    Atlanta, Georgia, 30331

Other trials in United States

About this study

Official title: Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women by SisterLove, Inc. in Atlanta, GA

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.

Read the 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.

Being tested
Healthy Love Workshop, HIV/AIDS 101 Workshop
Keywords
Adult, *HIV Infections/pc [Prevention & Control], Female, Humans, Risk-Taking, Safe Sex, Sexual Behavior, HIV Testing
Medical subject headings
HIV Infections, Sexually Transmitted Diseases, Risk-Taking, Safe Sex, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Love WorkshopBehavioural

    Also called Healthy Love Party, Healthy Love

    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.

  • HIV/AIDS 101 WorkshopBehavioural

    Also called HIV101

    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.

Study groups in NCT00362375
Study groupRoleWhat they receive
Healthy Love WorkshopExperimentalSingle-session, small-group HIV prevention intervention
Receives: Behavioral: Healthy Love Workshop
HIV101Active comparatorSingle-session, small-group intervention providing facts regarding HIV/AIDS
Receives: Behavioral: HIV/AIDS 101 Workshop

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Past 3 months

Secondary outcomes (4)
  1. 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

    Measured: Past 3 months

  2. HIV Knowledge

    Measured: current

  3. Condom Use Self-efficacy

    Measured: current

  4. Knowledge of HIV Test

    Measured: current

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00362375
Sponsor's protocol ID
CDC-NCHSTP-1927-4768
Other IDs
U65/CCU424514-02
Status last verified
Apr 2010
First submitted
8 Aug 2006
Last updated
14 May 2010
Data monitoring committee
No

Publications

  • 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.

    PubMed 20135214
  • 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.

    PubMed 24743662

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Healthy Love Workshop and HIV/AIDS 101 Workshop in people with HIV Infections and Sexually Transmitted Infections, run by Centers for Disease Control and Prevention at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Condom Use During Vaginal Sex With Any Male Partner (time frame: Past 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00362375, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2010.

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