HST for Female Sex Workers/Drug Users in Kazakhstan

NCT06150937 | Active Not Recruiting DMC

• 1 other identifier: R34DA049664
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 1.is the intervention acceptable and feasible
2. 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.

Conditions

HIV Testing; Intention

Keywords

Pre-exposure Prophylaxis; Post-exposure Prophylaxis; HIV self-testing

Outcome Measures

Primary Outcomes (4)

• HIV testing

  HIV testing (operationalized as 1+ test in past 3 mos. over follow-up) When was the last time you were tested for HIV? (6M\_HIV TEST LAST) 1. In the past 3 months 2. Not in the past 3 months, but in the past 6 months 3. Not in the past 6 months, but in the past year 4. Not in the past year, but in the past 3 years 5. More than 3 years ago 99\. Refuse to answer

  6 months

• Frequent HIV testing

  frequent HIV testing (2+ test within 6 mos. over follow-up) In the last 3 months, how many times have you tested for HIV? (6M\_HIV TEST TIMES) 0 (never) 1. time 2. times 3-4 times 5 or more times

  6 months

• HIV care linkage/ART initiation

  self-reported HIV care receipt and ART initiation For participant's who test positive, the study team engages in outreach and linkage to care, which is documented in the study file

  6 months

• Intention to uptake PrEP

  self-reported intention to use PrEP Have you heard of "PrEP" also known as pre exposure prophylaxis? In the last three months, have you spoken to a health care provider about PrEP to reduce the risk of HIV infection? In the last three months, have you taken PrEP to reduce the risk of HIV infection? Are you currently taking PrEP (pre-exposure prophylaxis)? Are you taking PrEP under a doctor or health care professional's supervision? Are you planning to take PrEP (pre-exposure prophylaxis)? Women who exchange sex and/or use drugs should take PrEP. Based on what I know about PrEP, I would prefer (RANK the options):

  6 months

Secondary Outcomes (2)

• incident STI

  12 months

• stigma-related outcomes

  12 months

Study Arms (2)

AEGIDA intervention arm

EXPERIMENTAL

Four session behavioral intervention to promote consistent HIV testing, frequent HIV testing and intention to uptake PEP/PrEP.

Behavioral: AEGIDA intervention arm

AEGIDA control arm

ACTIVE COMPARATOR

Four session didactic intervention to promote self-screening for common health problems, including HIV self-testing.

Behavioral: AEGIDA control arm

Interventions

AEGIDA intervention arm BEHAVIORAL

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.

AEGIDA intervention arm

AEGIDA control arm BEHAVIORAL

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.

AEGIDA control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• report vaginal or anal intercourse in past year in exchange for money, alcohol, drugs, or other goods/resources
• report having injected or used drugs and/or binged alcohol in past year
• report at least one episode of condomless sexual intercourse in past 90 days with a paying, casual, or regular (intimate) sexual partner
• HIV-negative as confirmed by rapid test at enrollment

You may not qualify if:

• have a cognitive or psychiatric impairment preventing comprehension of study procedures as assessed during Informed Consent
• do not speak and understand Russian at a conversational level
• previously enrolled in the pre-pilot portion of the study

Sponsors & Collaborators

• City University of New York: lead
• Columbia University: collaborator

Study Sites (1)

Global Health Research Center of Central Asia

Almaty, Kazakhstan

Location

Related Publications (1)

• West BS, Darisheva M, McCrimmon T, Chang M, Zholnerova N, Grigorchuk E, Starbird L, Terlikbayeva A, Primbetova S, Cordingley O, Baiserkin B, Kassymbekova S, Mussina Z, Rashidov I, Gilbert L, El-Bassel N, Frye V; AEGIDA Study Team; Key Community Partners. AEGIDA: Results of a Pilot Randomized Trial of an HIV Self-Testing Intervention for Women Who Exchange Sex and Use Substances in Kazakhstan. AIDS Behav. 2025 Nov 3. doi: 10.1007/s10461-025-04927-0. Online ahead of print.

  PMID: 41177842 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Professor

Model Details: Pilot RCT of a 4-session intervention. Participants will be randomized in a 2:1 intervention to control ratio and followed up for 12 months.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 30, 2023
• Study Start: November 15, 2022
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)