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WHC+ (Women's Health CoOp PLUS)

NCT01497405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 641

Last updated 2025-01-08

No results posted yet for this study

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

Interventions

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).

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • RTI International

    lead OTHER

Principal Investigators

  • Felicia Browne, ScD · RTI International

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497405 on ClinicalTrials.gov