WHC+ (Women's Health CoOp PLUS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by RTI International
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT01497405
First received: December 1, 2011
Last updated: August 10, 2014
Last verified: August 2014
  Purpose

This study compares the effects of standard HIV test, treat and retain (TTR) practices with TTR plus a woman-focused enhanced strategy--Women's Health CoOp (WHC+) intervention) targeting hard-to-reach and vulnerable alcohol and other drug (AOD)-using women to determine if the WHC+ intervention is more efficacious than TTR alone in reducing HIV risk behavior. Additionally, the study will determine whether HIV positive women in the WHC+ arm are more likely to follow through with referrals for further medical evaluation and linkages to HIV treatment and other care than women in the TTR arm.


Condition Intervention Phase
HIV
Sexual Risk
Sexually Transmitted Diseases
Substance Abuse
Violence
Victimization
Behavioral: Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)
Biological: Test, Treat, Retain(TTR) only
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Combination Prevention for Vulnerable Women in South Africa

Resource links provided by NLM:


Further study details as provided by RTI International:

Primary Outcome Measures:
  • Unprotected intercourse among women [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentages of condom use at last sex


Secondary Outcome Measures:
  • Medical evaluation initiation amongst HIV-positive [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentages of HIV-positive women receiving medical evaluations.

  • Treatment initiation and retention amongst HIV-positive women [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentages of HIV-positive women starting and staying in treatment

  • HIV viral load among HIV-positive women who meet criteria for ART and who produce medical records with HIV viral loads [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Alcohol use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of alcohol use in past 30 days measured by RRBA and breath test

  • Victimization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentages of women who report being beaten, attacked with a weapon, or forced to have sex in the previous 90 days


Estimated Enrollment: 600
Study Start Date: May 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test, Treat, Retain(TTR) only
Participants in this group will be screened for HIV. HIV positive women will be given post-test counseling and referrals for prompt medical evaluation.
Biological: Test, Treat, Retain(TTR) only
TTR +only: Participants in this group will be screened for HIV. HIV positive women will be given post-test counseling and referrals for prompt medical evaluation.
Experimental: Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)
TTR +WHC: Participants in this group will be screened for HIV. HIV positive women, will be given post-test counseling and referrals for prompt medical evaluation and assessment. Both HIV negative and positive participants in this group will participate in 2 individual behavioral counseling sessions focusing on reducing HIV risk behaviours, alcohol and other drug use, and risk of violent victimization. It also adds case management to increase follow through with referrals and risk reduction plans and activities. This intervention is an adaptation of the evidence-based Women's CoOp(PI: Dr. Wendee M. Wechsberg).
Behavioral: Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)
TTR +WHC: Participants in this group will be screened for HIV. HIV positive women, will be given post-test counseling and referrals for prompt medical evaluation and assessment.Both HIV negative and positive participants in this group will participate in 2 individual behavioral counseling sessions focusing on reducing HIV risk behaviours, alcohol and other drug use, and risk of violent victimization. It also adds case management to increase follow through with referrals and risk reduction plans and activities.This will also include case management sessions. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg).

Detailed Description:

There is growing recognition that no single strategy will be sufficient to eliminate transmission. In light of evidence that neither existing biomedical interventions nor any existing behavioral interventions will be sufficient to control the HIV epidemic in South Africa, the proposed study will combine a biomedical intervention with an evidence-based behavioral intervention (i.e., the Women's Health CoOp) to maximize the efficacy of both strategies. If this combination intervention proves efficacious, there is a high likelihood that it can be widely implemented, be sustainable and have a substantial public health impact by reducing the exceedingly high HIV incidence in South Africa.

The overarching goal of the proposed research is to determine whether this enhanced combination prevention strategy targeting vulnerable AOD-using women is more efficacious than current standard practices. The specific aims of the proposed study are:

Aim 1: To expand the WHC outreach strategies to reach more alcohol and other drug (AOD) - using vulnerable women in Pretoria, South Africa.

Aim 2: To test whether adding WHC to standard Treat, Test, and Retain (TTR) practices results in more HIV-positive AOD-using women getting medical evaluations (e.g., CD4, viral load), starting treatment, staying in treatment and in greater reductions in risk behaviors (e.g., AOD use, condom use, victimization) among all women-positive or negative.

The study uses a geographical cluster randomized design. Hotspots (i.e. places where sex workers and drug using women congregate) in the city of Pretoria and the surrounding areas were mapped using GIS software. Fourteen hotspots were identified and geocoded. The entire area was divided into 14 zones, each of which included a hotspot. Seven matched pairs of zones were created based on socio-economic conditions and estimates of the numbers of sex workers and drug-using women residing in them. Zones within pairs were randomized to the TTR arm or the WHC+ arm. Participants are recruited by outreach workers and their intervention condition is based on the zone from which they were recruited. At study enrollment/baseline, eligible participants complete a questionnaire and baseline HIV, drug and pregnancy testing. Follow-up data collection will be conducted at 6-months and 12-months post-baseline.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female
  2. Black/African
  3. 15 years or older (if under 18, must be able to sign assent)
  4. Use at least one of the following drugs: alcohol, marijuana (dagga), methamphetamine (tik), Mandrax (methaqualone), cocaine (crack and/or powder), heroin (Thai White), inhalants (glue and benzene) MDMA (ecstasy), LSD, or Kat/cat, Nyaope (a mixture of marijuana and heroin) — weekly in the past 90 days
  5. Have had unprotected vaginal sex with a male partner in the last six months
  6. Able to speak English, Sesotho, Tswana, or Zulu
  7. Consent to HIV rapid testing and drug testing
  8. Provide written verbal and assent/consent to participate
  9. Able to provide verifiable locator information for the Tshwane area and plan to stay there in the next 12 months

Exclusion Criteria:

  1. Males
  2. Individuals who do not self-identify as Black/African
  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: NCT01497405

Contacts
Contact: Wendee Wechsberg, PhD 800-334-8571 wmw@rti.org
Contact: Connie C Kekwaletswe, PhD +27 (0) 12 339-8504 connie@raymk.com

Locations
United States, North Carolina
RTI International - Headquarters Recruiting
Research Triangle Park, North Carolina, United States, 27709
Contact: Wendee M Wechsberg, PhD    800-334-8571    wmw@rti.org   
Principal Investigator: Wendee M Wechsberg, PhD         
Sub-Investigator: William A Zule, DrPH         
South Africa
Wesley Community Centre Recruiting
Pretoria, South Africa, 0126
Contact: Deacon F Madjoe    +27 (0)12 322 7428/9    fmadjoe@weschurch.co.za   
Sub-Investigator: Connie C Kekwaletswe, PhD         
Sponsors and Collaborators
RTI International
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Wendee M Wechsberg, PhD RTI International
Principal Investigator: Connie C Kekwaletswe, PhD FHI 360
  More Information

Additional Information:
No publications provided

Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT01497405     History of Changes
Other Study ID Numbers: 1R01DA032061-01
Study First Received: December 1, 2011
Last Updated: August 10, 2014
Health Authority: South Africa: Department of Health

Keywords provided by RTI International:
Gender-based Violence
HIV
Randomized Controlled Trial
Sexually Transmitted Diseases
Substance Abuse Detection
Test, Treat and Retain

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014