Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

14 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

232

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Uptake of HIV/STI testing through the strategy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
HIV incidence
Tidsram: 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
Tidsram: At enrollment.
Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.
At enrollment.
Syphilis prevalence
Tidsram: At enrollment.
Diagnosed with syphilis at enrollment (of those participating at intervention sites).
At enrollment.
Syphilis incidence
Tidsram: 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
Tidsram: At enrollment.
Diagnosed with gonorrhea at enrollment (of those participating at intervention sites).
At enrollment.
Gonorrhea incidence
Tidsram: 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
Tidsram: At enrollment.
Diagnosed with chlamydia at enrollment (of those participating at intervention sites).
At enrollment.
Chlamydia incidence
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of North Carolina, Chapel Hill

Samarbetspartners

Fogarty International Center of the National Institute of Health

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

14 september 2026

Först inskickad som uppfyllde QC-kriterierna

14 september 2026

Första postat (Faktisk)

18 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 26-1772
  • D43TW009340 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera