Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)
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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Stephanie F Sweitzer, MSPH, MD
- Telefonnummer: +260572003688
- E-Mail: Stephanie.Sweitzer@unchealth.unc.edu
Studienorte
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Lusaka Province
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Lusaka, Lusaka Province, Sambia, 10101
- Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office
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Kontakt:
- Stephanie Sweitzer, MSPH, MD
- Telefonnummer: +260572003688
- E-Mail: Stephanie.Sweitzer@unchealth.unc.edu
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
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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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Uptake of HIV/STI testing through the strategy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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HIV incidence
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: Stephanie F Sweitzer, MSPH, MD, University of North Carolina
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Pathologische Prozesse
- Krankheitsattribute
- Infektionen
- Übertragbare Krankheiten
- Bakterielle Infektionen
- Bakterielle Infektionen und Mykosen
- Gramnegative bakterielle Infektionen
- Spirochäten-Infektionen
- Chlamydiaceae-Infektionen
- Sexuell übertragbare Krankheiten, bakteriell
- Neisseriaceae-Infektionen
- Treponema-Infektionen
- Pathologische Zustände, Anzeichen und Symptome
- Sexuell übertragbare Krankheiten
- Chlamydien-Infektionen
- Tripper
- Syphilis
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 26-1772
- D43TW009340 (US NIH Stipendium/Vertrag)
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