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

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

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 Overview

• Status: Not yet recruiting
• Conditions: HIV; Chlamydia; Gonorrhea; Syphilis
• Intervention / Treatment: Other: Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie F Sweitzer, MSPH, MD; Phone Number: +260572003688; Email: Stephanie.Sweitzer@unchealth.unc.edu

Study Locations

• Zambia
  • Lusaka Province
    • Lusaka, Lusaka Province, Zambia, 10101
      • Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office
      • Contact: Stephanie Sweitzer, MSPH, MD; Phone Number: +260572003688; Email: Stephanie.Sweitzer@unchealth.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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; 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.
No Intervention: Standard-of-Care Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV incidence	New HIV diagnoses among those with negative HIVST at enrollment and no known history of HIV prior to enrollment at intervention sites.	Between enrollment and study follow up at 3 months post-enrollment.
HIV prevalence	Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.	At enrollment.
Syphilis prevalence	Diagnosed with syphilis at enrollment (of those participating at intervention sites).	At enrollment.
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).	Between enrollment and study follow up at 3 months post-enrollment.
Gonorrhea prevalence	Diagnosed with gonorrhea at enrollment (of those participating at intervention sites).	At enrollment.
Gonorrhea incidence	Diagnosed with gonorrhea at/before the 3-month study follow up visit (among those with negative gonorrhea testing at enrollment or who completed gonorrhea treatment at enrollment at intervention sites).	Between enrollment and study follow up at 3 months post-enrollment.
Chlamydia prevalence	Diagnosed with chlamydia at enrollment (of those participating at intervention sites).	At enrollment.
Chlamydia incidence	Diagnosed with chlamydia at/before the 3-month study follow up visit (among those with negative chlamydia testing at enrollment or who completed chlamydia treatment at enrollment at intervention sites).	Between enrollment and study follow up at 3 months post-enrollment.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Stephanie F Sweitzer, MSPH, MD, University of North Carolina

Publications and helpful links

General Publications

• 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.
• 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/
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Implementation science; Sexually transmitted infections; Female sex workers
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Treponemal Infections; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Chlamydia Infections; Gonorrhea; Syphilis
• Other Study ID Numbers: 26-1772; D43TW009340 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Given the concern that sharing identifiable data could violate participant privacy around potentially stigmatizing information, this data will not be shared outside of the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes