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

14 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

232

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Outro: 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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Uptake of HIV/STI testing through the strategy
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
HIV incidence
Prazo: 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
Prazo: At enrollment.
Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.
At enrollment.
Syphilis prevalence
Prazo: At enrollment.
Diagnosed with syphilis at enrollment (of those participating at intervention sites).
At enrollment.
Syphilis incidence
Prazo: 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
Prazo: At enrollment.
Diagnosed with gonorrhea at enrollment (of those participating at intervention sites).
At enrollment.
Gonorrhea incidence
Prazo: 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
Prazo: At enrollment.
Diagnosed with chlamydia at enrollment (of those participating at intervention sites).
At enrollment.
Chlamydia incidence
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of North Carolina, Chapel Hill

Colaboradores

Fogarty International Center of the National Institute of Health

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

14 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de setembro de 2026

Primeira postagem (Real)

18 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 26-1772
  • D43TW009340 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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