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

maanantai 14. syyskuuta 2026 päivittänyt: University of North Carolina, Chapel Hill

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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

232

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Sambia
    • Lusaka Province
      • Lusaka, Lusaka Province, Sambia, 10101
        • Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Joo

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Muut: 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.
Ei väliintuloa: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Uptake of HIV/STI testing through the strategy
Aikaikkuna: 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.
From enrollment to study follow up at 3 months post-enrollment.
Uptake of HIV testing
Aikaikkuna: 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.
From enrollment to study follow up at 3 months post-enrollment.
Completion of confirmatory HIV testing
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
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
Aikaikkuna: 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.
From enrollment to study follow up at 3 months post-enrollment.
HIV treatment linkage
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
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
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
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
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
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
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
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
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
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
Aikaikkuna: 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).
From enrollment to study follow up at 3 months post-enrollment.
STI syndromic diagnosis
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
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
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
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
Aikaikkuna: 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.
At enrollment and at study follow up 3 months post-enrollment.
Strategy appropriateness
Aikaikkuna: 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.
At enrollment and at study follow up 3 months post-enrollment.
Strategy feasibility
Aikaikkuna: 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.
At enrollment and at study follow up 3 months post-enrollment.
Strategy costs
Aikaikkuna: From enrollment to study follow up at 3 months post-enrollment.
Variable and fixed costs associated with the strategy and expressed per participant.
From enrollment to study follow up at 3 months post-enrollment.

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
HIV incidence
Aikaikkuna: 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.
Between enrollment and study follow up at 3 months post-enrollment.
HIV prevalence
Aikaikkuna: At enrollment.
Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.
At enrollment.
Syphilis prevalence
Aikaikkuna: At enrollment.
Diagnosed with syphilis at enrollment (of those participating at intervention sites).
At enrollment.
Syphilis incidence
Aikaikkuna: 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).
Between enrollment and study follow up at 3 months post-enrollment.
Gonorrhea prevalence
Aikaikkuna: At enrollment.
Diagnosed with gonorrhea at enrollment (of those participating at intervention sites).
At enrollment.
Gonorrhea incidence
Aikaikkuna: 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).
Between enrollment and study follow up at 3 months post-enrollment.
Chlamydia prevalence
Aikaikkuna: At enrollment.
Diagnosed with chlamydia at enrollment (of those participating at intervention sites).
At enrollment.
Chlamydia incidence
Aikaikkuna: 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).
Between enrollment and study follow up at 3 months post-enrollment.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of North Carolina, Chapel Hill

Yhteistyökumppanit

Fogarty International Center of the National Institute of Health

Tutkijat

  • Päätutkija: Stephanie F Sweitzer, MSPH, MD, University of North Carolina

Julkaisuja ja hyödyllisiä linkkejä

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Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

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Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 14. syyskuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Perjantai 18. syyskuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 18. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

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Viimeksi vahvistettu

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Lisää tietoa

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Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 26-1772
  • D43TW009340 (Yhdysvaltain NIH-apuraha/sopimus)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Joo

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