HST for Female Sex Workers/Drug Users in Kazakhstan

NCT06150937 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-02-05

No results posted yet for this study

Summary

The goal of this behavioral intervention clinical trial is to assess acceptability, feasibility, and preliminary efficacy of a 4-session intervention to increase consistent HIV testing and linkage to care and prevention among HIV uninfected (assessed via on-site testing) female sex workers who use drugs in Kazakhstan.

The main question it aims to answer are:

1. is the intervention acceptable and feasible
2. do participants randomized to the intervention arm report: 1) past 3-month testing; 2) frequent testing (2+ test over 6 mos.); 3) linkage to HIV care and ART initiation, if positive, or intention to uptake PrEP, if negative, as compared with control arm participants. Secondary outcomes include incident, biologically-confirmed STIs and stigma-related factors. Follow-up period is six months.

All participants will be HIV-negative upon study enrollment as assessed via rapid HIV test.

Participants randomized to the intervention arm will be engaged in a 4-session intervention that offers training and education in HIV self-testing, peer education on HIV self-testing, internalized stigma coping and resistance via basic cognitive restructuring, and provision of HIV self-test kits and reminders every three months. Researchers will compare participants randomized to the intervention arm to participants randomized to the time- and attention-control arm to evaluate impact of the intervention on the outcomes described above.

Conditions

  • HIV Testing
  • Intention

Interventions

BEHAVIORAL

AEGIDA intervention arm

The intervention arm has 4 sessions facilitated one-on-one by trained staff and lasting \~40 minutes. The first session focuses on establishing rapport, assessing HIV risk, and educating/training participants on HIV self-testing/PEP/PrEP. The second session on peer education/training, barriers to and facilitators of testing, and supporting peers in receiving reactive and/or indeterminate HIV test results, as well as self-care. The third session on stigma and discrimination and techniques to cope with and resist stigma. The final session is a culminating one focused on reviewing key skills and health promotion planning conducted in first three sessions. The intervention arm applies anti-intersectional stigma, empowerment, and harm reduction approaches. All participants will receive/have access to HIV self-test kits every three months.

BEHAVIORAL

AEGIDA control arm

The control arm has 4 sessions via one-on-one facilitation by a trained facilitator and lasting \~40 minutes. It includes basic information on self-screening for common adverse health conditions among women in Kazakhstan, including STIs and HIV, as well as information on testing and risk reduction. All participants will receive/have access to HIV self-test kits every three months.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2024-04-01
Completion
2024-08-31

Countries

  • Kazakhstan

Study Locations

More Related Trials

Entities

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 NCT06150937 on ClinicalTrials.gov