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

NCT07829133 | Not Yet Recruiting

• 2 other identifiers: 26-1772D43TW009340
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Syphilis; Gonorrhea; Chlamydia

Keywords

Sexually transmitted infections; Female sex workers; Implementation science; HIV

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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).

  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).

  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)

  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).

  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.

  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.

  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.

  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.

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

Other Outcomes (8)

• HIV incidence

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

• HIV prevalence

  At enrollment.

• Syphilis prevalence

  At enrollment.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

At intervention sites, the investigators will consecutively enroll 50 female sex workers (FSW) per site and follow them for 3 months, with questionnaire administration, HIV self-testing (HIVST), and self-collected STI testing performed at enrollment and 3 months post-enrollment. At enrollment, participants will complete a one-time questionnaire on sociodemographic data, sexual history, medical history, and strategy acceptability and appropriateness, as well as HIVST and self-collected STI testing, with the assistance of queen mothers. 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 facilities per participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues/DICs/health facilities per participant preference. HIVST and self-collected STI testing and questionnaires repeated 3 months after enrollment.

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

Standard-of-Care Arm

NO INTERVENTION

At standard-of-care (SOC) sites, the investigators will enroll 50 FSW at each site for completion of study questionnaires at enrolment and at 3-month follow up. These FSW will continue receiving routine syndromic STI management and HIV screening and treatment as recommended by Zambian guidelines.

Interventions

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

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office

Lusaka, Lusaka Province, 10101, Zambia

Location

Related Publications (4)

• Guidelines for the management of symptomatic sexually transmitted infections [Internet]. Geneva: World Health Organization; 2021 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK572659/

  PMID: 34370424 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Wall KM, Kilembe W, Inambao M, Chen YN, Mchoongo M, Kimaru L, Hammond YT, Sharkey T, Malama K, Fulton TR, Tran A, Halumamba H, Anderson S, Kishore N, Sarwar S, Finnegan T, Mark D, Allen SA. Implementation of an electronic fingerprint-linked data collection system: a feasibility and acceptability study among Zambian female sex workers. Global Health. 2015 Jun 27;11:27. doi: 10.1186/s12992-015-0114-z.

  PMID: 26115656 BACKGROUND

• Evens E, Munthali T, Mangunje F, Kotaka ML, Burke HM, Musonda B, Musonda M, Todd CS. Qualitative focus group discussions exploring PrEP method and service delivery preferences among female sex workers and their managers in four Zambian provinces. BMJ Public Health. 2024 Feb 22;2(1):e000483. doi: 10.1136/bmjph-2023-000483. eCollection 2024 Jun.

  PMID: 40018231 BACKGROUND

MeSH Terms

Conditions

Syphilis; Gonorrhea; Chlamydia Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; Chlamydiaceae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie F Sweitzer, MSPH, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie F Sweitzer, MSPH, MD

CONTACT

+260572003688; Stephanie.Sweitzer@unchealth.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will utilize a parallel pilot cohort study design to pilot the strategy at two purposively selected venues (i.e., sites where FSW socialize and meet new sex partners) in Lusaka, Zambia, and compare to standard of care (SOC, syndromic treatment for symptomatic FSW) at two SOC sites.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)