Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)
14 de septiembre de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
232
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Stephanie F Sweitzer, MSPH, MD
- Número de teléfono: +260572003688
- Correo electrónico: Stephanie.Sweitzer@unchealth.unc.edu
Ubicaciones de estudio
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Lusaka Province
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Lusaka, Lusaka Province, Zambia, 10101
- Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office
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Contacto:
- Stephanie Sweitzer, MSPH, MD
- Número de teléfono: +260572003688
- Correo electrónico: Stephanie.Sweitzer@unchealth.unc.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Uptake of HIV/STI testing through the strategy
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Completion of HIV self-testing and self-collected STI testing among those offered HIV self-testing and self-collected STI testing through the strategy.
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From enrollment to study follow up at 3 months post-enrollment.
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Uptake of HIV testing
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Completion of HIV testing among those not known to be living with HIV at enrollment.
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From enrollment to study follow up at 3 months post-enrollment.
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Completion of confirmatory HIV testing
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Completion of confirmatory HIV testing among those with positive HIV self tests.
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From enrollment to study follow up at 3 months post-enrollment.
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HIV diagnosis
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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New diagnosis of HIV among those not known to be living with HIV at enrollment.
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From enrollment to study follow up at 3 months post-enrollment.
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HIV treatment linkage
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Registered in the Zambian national HIV program (of those with HIV).
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From enrollment to study follow up at 3 months post-enrollment.
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HIV prevention linkage
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Registered in the national HIV program (of those not living with HIV).
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From enrollment to study follow up at 3 months post-enrollment.
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Uptake of self-collected STI testing
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Completed self-collected STI testing (of those offered testing through the strategy).
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From enrollment to study follow up at 3 months post-enrollment.
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Uptake of self-collected syphilis testing
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Completed self-collected syphilis testing (of those offered testing through the strategy).
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From enrollment to study follow up at 3 months post-enrollment.
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Uptake of self-collected gonorrhea/chlamydia testing
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Completed self-collected gonorrhea/chlamydia testing (of those offered testing through the strategy).
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From enrollment to study follow up at 3 months post-enrollment.
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STI diagnosis
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Diagnosed with one or more microbiologically confirmed STIs (of those participating at intervention sites).
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From enrollment to study follow up at 3 months post-enrollment.
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STI syndromic diagnosis
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Diagnosed with one or more STI syndromes (of those participating at SOC sites)
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From enrollment to study follow up at 3 months post-enrollment.
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STI treatment linkage
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Received STI treatment (of those diagnosed with STIs and/or STI syndromes).
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From enrollment to study follow up at 3 months post-enrollment.
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Strategy acceptability
Periodo de tiempo: At enrollment and at study follow up 3 months post-enrollment.
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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.
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At enrollment and at study follow up 3 months post-enrollment.
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Strategy appropriateness
Periodo de tiempo: At enrollment and at study follow up 3 months post-enrollment.
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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.
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At enrollment and at study follow up 3 months post-enrollment.
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Strategy feasibility
Periodo de tiempo: At enrollment and at study follow up 3 months post-enrollment.
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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.
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At enrollment and at study follow up 3 months post-enrollment.
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Strategy costs
Periodo de tiempo: From enrollment to study follow up at 3 months post-enrollment.
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Variable and fixed costs associated with the strategy and expressed per participant.
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From enrollment to study follow up at 3 months post-enrollment.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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HIV incidence
Periodo de tiempo: Between enrollment and study follow up at 3 months post-enrollment.
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New HIV diagnoses among those with negative HIVST at enrollment and no known history of HIV prior to enrollment at intervention sites.
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Between enrollment and study follow up at 3 months post-enrollment.
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HIV prevalence
Periodo de tiempo: At enrollment.
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Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.
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At enrollment.
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Syphilis prevalence
Periodo de tiempo: At enrollment.
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Diagnosed with syphilis at enrollment (of those participating at intervention sites).
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At enrollment.
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Syphilis incidence
Periodo de tiempo: Between enrollment and study follow up at 3 months post-enrollment.
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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).
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Between enrollment and study follow up at 3 months post-enrollment.
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Gonorrhea prevalence
Periodo de tiempo: At enrollment.
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Diagnosed with gonorrhea at enrollment (of those participating at intervention sites).
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At enrollment.
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Gonorrhea incidence
Periodo de tiempo: Between enrollment and study follow up at 3 months post-enrollment.
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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).
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Between enrollment and study follow up at 3 months post-enrollment.
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Chlamydia prevalence
Periodo de tiempo: At enrollment.
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Diagnosed with chlamydia at enrollment (of those participating at intervention sites).
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At enrollment.
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Chlamydia incidence
Periodo de tiempo: Between enrollment and study follow up at 3 months post-enrollment.
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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).
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Between enrollment and study follow up at 3 months post-enrollment.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Stephanie F Sweitzer, MSPH, MD, University of North Carolina
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
14 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Procesos Patológicos
- Atributos de la enfermedad
- Infecciones
- Enfermedades contagiosas
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias gramnegativas
- Infecciones por espiroquetas
- Infecciones por clamidias
- Enfermedades De Transmisión Sexual Bacterianas
- Infecciones por Neisseriaceae
- Infecciones treponémicas
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de transmisión sexual
- Infecciones por clamidia
- Gonorrea
- Sífilis
Otros números de identificación del estudio
- 26-1772
- D43TW009340 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .