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Mixed-methods Protocol for the WiSSPr Study

Mixed-methods Protocol for the WiSSPr Study: Women in Sex Work, Stigma and Psychosocial Barriers to Pre-exposure Prophylaxis in Zambia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06898112
Acronym
WiSSPr
Enrollment
299
Registered
2025-03-27
Start date
2023-07-18
Completion date
2024-03-31
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PrEP Uptake

Keywords

stigma, prep, sex work, women, zambia, southern africa, community-based participatory research, community advisory board

Brief summary

WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH).

Detailed description

WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). We will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). We will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. We seek to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants' lived experiences. https://doi.org/10.1136/bmjopen-2023-080218

Interventions

DRUGPrEP

oral PrEP

Sponsors

Fogarty International Center of the National Institute of Health
CollaboratorNIH
University of Washington
CollaboratorOTHER
Centre for Infectious Disease Research in Zambia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Inclusion criteria: (1) identify as a cis-gendered or transgendered woman, (2) age ≥ 18 years, (3) earns a significant amount of income from exchanging sex for money or goods in the last 3 months, (4) HIV-negative status and eligible for PrEP according to national guidelines, (5) not planning to transfer care to another site within the next 30 days, (6) speaks English or ChiNyanja or IchiBemba and (7) willing and able to provide written informed consent

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
PrEP initiation (#/% ever taken PrEP)3 monthsPrEP initiation (Number or percentage of Women Engaging in Sex Work (WESW) initiating on PrEP)
PrEP Persistence (#/ % eligible refills obtained until first discontinuation)3 monthsPrEP persistence. Number or percentage of women engaging in sex work with high levels of stigma who will persist on PrEP

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026