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NCT Number: NCT07829133

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Lusaka, Lusaka Province, 10101, Zambia

Location contact

Stephanie Sweitzer, MSPH, MD

CONTACT

[email protected]

+260572003688

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Uptake of HIV/STI testing through the strategy

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

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

  2. Uptake of HIV testing

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

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

  3. Completion of confirmatory HIV testing

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

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

  4. HIV diagnosis

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

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

  5. HIV treatment linkage

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

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

  6. HIV prevention linkage

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

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

  7. Uptake of self-collected STI testing

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

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

  8. Uptake of self-collected syphilis testing

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

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

  9. Uptake of self-collected gonorrhea/chlamydia testing

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

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

  10. STI diagnosis

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

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

  11. STI syndromic diagnosis

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

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

  12. STI treatment linkage

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

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

  13. Strategy acceptability

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

    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.

  14. Strategy appropriateness

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

    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.

  15. Strategy feasibility

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

    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.

  16. Strategy costs

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

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

Other outcomes

  1. HIV incidence

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

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

  2. HIV prevalence

    Time frame: At enrollment.

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

  3. Syphilis prevalence

    Time frame: At enrollment.

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

  4. Syphilis incidence

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

    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).

  5. Gonorrhea prevalence

    Time frame: At enrollment.

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

  6. Gonorrhea incidence

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

    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).

  7. Chlamydia prevalence

    Time frame: At enrollment.

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

  8. Chlamydia incidence

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie F Sweitzer, MSPH, MD

CONTACT

[email protected]

+260572003688

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

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

Acronym: PHASES

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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