Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study

N/ANot Yet RecruitingNCT07829133

University of North Carolina, Chapel Hill232 enrolled

Overview

The goal of this clinical trial is to find out if sex work managers (also called "queen mothers") can help female sex workers (FSW) get tested for HIV and other sexually transmitted infections (STIs) by giving out and collecting test kits at the places where FSW meet and work, also known as venues. This study will also find out if this approach helps link FSW to HIV and STI treatment and prevention services. The main questions it aims to answer are: * Can this approach increase HIV diagnosis and connection to HIV treatment and prevention services? * Can this approach increase STI diagnosis and connection to STI treatment services? * Is this approach acceptable, appropriate, and feasible, and what are the costs associated with the approach? Researchers will compare a venue-based, peer-supported strategy for HIV self-testing and self-collected STI testing among FSW to the current standard of care to see if the new approach helps to increase HIV and STI identification and linkage to HIV and STI treatment and prevention services. FSW participants will: * Complete questionnaires when they join the study and again about three months later. * Complete HIV self-testing and self-collected STI testing when they join the study and again about three months later (at intervention sites), with the help of queen mothers. * Agree to have their medical records reviewed. Queen mother participants will: * Complete questionnaires when they join the study and again about three months later. * Help FSW participant complete HIV self-testing and self-collected STI testing when they join the study and again three months later (at intervention sites). Additionally, some FSW participants will complete a one-time interview so that the investigators can learn more about their experiences with and views on HIV and STI services. The investigators will also be holding focus group discussions with queen mothers, clinicians, and others involved in study activities to understand their experiences with providing services through the study strategy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

Interventions

Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testingOTHER

Sex work managers, known as "queen mothers", will act as peer champions and will store, distribute, and collect HIV self-tests and self-collected STI test kits at venues where sex is sold on-site. Participants diagnosed with HIV and/or STIs will be linked to World Health Organization (WHO)-recommended treatment at venues or nearby drop-in centers (DICs) or Ministry of Health (MOH) health facilities based on participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues or DICs or health facilities based on participant preference.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

FSW Inclusion Criteria: * Born biologically female * Identifies as a woman * Aged 18 years or older * Exchanged sex for money, goods, or services in the last 6 months * Lived and/or worked in Lusaka for at least the last 3 months * Planning to remain in Lusaka for at least the next 3 months * Willing and able to provide contact information, including a reachable telephone number * Willing and able to provide informed consent in Nyanja, Bemba, or English FSW Exclusion Criteria: * Under the age of 18 years * Does not identify as a woman * Unable and/or unwilling to provide contact information * Unable and/or unwilling to provide informed consent Queen Mother Eligibility Criteria: * Aged 18 years or older * Currently engaged as a sex work manager ("queen mother") * Lived and/or worked in Lusaka for at least the last 3 months * Planning to remain in Lusaka for at least the next 6 months * Willing and able to provide contact information, including a reachable telephone number * Willing and able to provide informed consent in Nyanja, Bemba, or English Implementer Focus Group Discussion Eligibility Criteria: * Aged 18 years old or older * Working as a queen mother OR civil society organization/Ministry of Health/non-governmental organization clinician or peer navigator OR member of a civil society or implementing partner organization serving FSW * Willing and able to provide verbal informed consent in English, Nyanja, or Bemba

Outcomes

Primary Outcomes

Uptake of HIV/STI testing through the strategy

Completion of HIV self-testing and self-collected STI testing among those offered HIV self-testing and self-collected STI testing through the strategy.

Time frame: From enrollment to study follow up at 3 months post-enrollment.

Uptake of HIV testing

Completion of HIV testing among those not known to be living with HIV at enrollment.

Time frame: From enrollment to study follow up at 3 months post-enrollment.

Completion of confirmatory HIV testing

Completion of confirmatory HIV testing among those with positive HIV self tests.

Time frame: From enrollment to study follow up at 3 months post-enrollment.

HIV diagnosis

New diagnosis of HIV among those not known to be living with HIV at enrollment.

Time frame: From enrollment to study follow up at 3 months post-enrollment.

HIV treatment linkage

Registered in the Zambian national HIV program (of those with HIV).

Time frame: From enrollment to study follow up at 3 months post-enrollment.

HIV prevention linkage

Registered in the national HIV program (of those not living with HIV).

Time frame: From enrollment to study follow up at 3 months post-enrollment.

Uptake of self-collected STI testing

Completed self-collected STI testing (of those offered testing through the strategy).

Time frame: From enrollment to study follow up at 3 months post-enrollment.

Uptake of self-collected syphilis testing

Completed self-collected syphilis testing (of those offered testing through the strategy).

Time frame: From enrollment to study follow up at 3 months post-enrollment.

Uptake of self-collected gonorrhea/chlamydia testing

Completed self-collected gonorrhea/chlamydia testing (of those offered testing through the strategy).

Time frame: From enrollment to study follow up at 3 months post-enrollment.

STI diagnosis

Diagnosed with one or more microbiologically confirmed STIs (of those participating at intervention sites).

Time frame: From enrollment to study follow up at 3 months post-enrollment.

STI syndromic diagnosis

Diagnosed with one or more STI syndromes (of those participating at SOC sites)

Time frame: From enrollment to study follow up at 3 months post-enrollment.

STI treatment linkage

Received STI treatment (of those diagnosed with STIs and/or STI syndromes).

Time frame: From enrollment to study follow up at 3 months post-enrollment.

Strategy acceptability

Acceptability of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers, using the Acceptability of Intervention Measure.

Time frame: At enrollment and at study follow up 3 months post-enrollment.

Strategy appropriateness

Appropriateness of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers using the Intervention Appropriateness Measure.

Time frame: At enrollment and at study follow up 3 months post-enrollment.

Strategy feasibility

Feasibility of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among implementers using the Feasibility of Intervention Measure.

Time frame: At enrollment and at study follow up 3 months post-enrollment.

Strategy costs

Variable and fixed costs associated with the strategy and expressed per participant.

Time frame: From enrollment to study follow up at 3 months post-enrollment.

Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts