WHC+ (Women's Health CoOp PLUS)

NCT01497405 | Completed Phase 1 DMC

• 1 other identifier: 1R01DA032061-01
• Study Type: interventional
• Target: 641
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

HIV; Sexual Risk; Sexually Transmitted Diseases; Substance Abuse; Violence; Victimization

Keywords

Gender-based Violence; HIV; Randomized Controlled Trial; Sexually Transmitted Diseases; Substance Abuse Detection; Test, Treat and Retain

Outcome Measures

Primary Outcomes (2)

• Unprotected intercourse among women

  Percentages of condom use at last sex

  6 months

• Unprotected intercourse among women

  Percentages of condom use at last sex

  12 months

Secondary Outcomes (10)

• Medical evaluation initiation amongst HIV-positive

  6 months

• Medical evaluation initiation amongst HIV-positive

  12 months

• Treatment initiation and retention amongst HIV-positive women

  6 months

• Treatment initiation and retention amongst HIV-positive women

  12 months

• HIV viral load among HIV-positive women who meet criteria for antiretroviral treatment (ART) and who produce medical records with HIV viral loads

  6 months

Study Arms (2)

Test, Treat, Retain(TTR) only

ACTIVE COMPARATOR

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

Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)

EXPERIMENTAL

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)

Interventions

Test, Treat, Retain(TTR) + Women's Health CoOp (WHC) BEHAVIORAL

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).

Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)

Test, Treat, Retain(TTR) only BIOLOGICAL

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.

Test, Treat, Retain(TTR) only

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• Black/African
• years or older (if under 18, must be able to sign assent)
• 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) methylenedioxymethamphetamine (MDMA -ecstasy), lysergic acid diethylamide (LSD), or Kat/cat, Nyaope (a mixture of marijuana and heroin) - weekly in the past 90 days
• Have had unprotected vaginal sex with a male partner in the last six months
• Able to speak English, Sesotho, Tswana, or Zulu
• Consent to HIV rapid testing and drug testing
• Provide written verbal and assent/consent to participate
• Able to provide verifiable locator information for the Tshwane area and plan to stay there in the next 12 months

You may not qualify if:

• Males
• Individuals who do not self-identify as Black/African

Sponsors & Collaborators

• RTI International: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

RTI International - Headquarters

Research Triangle Park, North Carolina, 27709, United States

Location

Wesley Community Centre

Pretoria, 0126, South Africa

Location

Related Publications (4)

• Wechsberg WM, Deren S, Myers B, Kirtadze I, Zule WA, Howard B, El-Bassel N. Gender-Specific HIV Prevention Interventions for Women Who Use Alcohol and Other Drugs: The Evolution of the Science and Future Directions. J Acquir Immune Defic Syndr. 2015 Jun 1;69 Suppl 2(0 1):S128-39. doi: 10.1097/QAI.0000000000000627.

  PMID: 25978479 BACKGROUND

• Wechsberg WM, Peasant C, Kline T, Zule WA, Ndirangu J, Browne FA, Gabel C, van der Horst C. HIV Prevention Among Women Who Use Substances And Report Sex Work: Risk Groups Identified Among South African Women. AIDS Behav. 2017 Nov;21(Suppl 2):155-166. doi: 10.1007/s10461-017-1889-0.

  PMID: 28887751 DERIVED

• Wechsberg WM, van der Horst C, Ndirangu J, Doherty IA, Kline T, Browne FA, Belus JM, Nance R, Zule WA. Seek, test, treat: substance-using women in the HIV treatment cascade in South Africa. Addict Sci Clin Pract. 2017 Apr 26;12(1):12. doi: 10.1186/s13722-017-0077-x.

  PMID: 28441975 DERIVED

• Wechsberg WM, Zule WA, Ndirangu J, Kline TL, Rodman NF, Doherty IA, Novak SP, van der Horst CM. The biobehavioral Women's Health CoOp in Pretoria, South Africa: study protocol for a cluster-randomized design. BMC Public Health. 2014 Oct 15;14:1074. doi: 10.1186/1471-2458-14-1074.

  PMID: 25318563 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Substance-Related Disorders

Interventions

Coal Tar; Single Person

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Felicia Browne, ScD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 22, 2011
• Study Start: May 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

ZA (1); US (1)