Health TrialsbyHealthPanel

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

ConditionsHIVSyphilisGonorrheaChlamydia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Born biologically female

Identifies as a woman

Aged 18 years or older

Exchanged sex for money, goods, or services in the last 6 months

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Standard-of-Care ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

Other outcomes

1

HIV incidence

New HIV diagnoses among those with negative HIVST at enrollment and no known history of HIV prior to enrollment at intervention sites.

Time frame
Between enrollment and study follow up at 3 months post-enrollment.
2

HIV prevalence

Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.

Time frame
At enrollment.
3

Syphilis prevalence

Diagnosed with syphilis at enrollment (of those participating at intervention sites).

Time frame
At enrollment.
4

Syphilis incidence

Diagnosed with syphilis at/before the 3-month study follow up visit (among those with negative syphilis testing at enrollment or those who were diagnosed with syphilis at enrollment and completed syphilis treatment at intervention sites).

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Fogarty International Center of the National Institute of Health

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: