Clinical trial NCT06898112: Mixed-methods Protocol for the WiSSPr Study
Official title: Mixed-methods Protocol for the WiSSPr Study: Women in Sex Work, Stigma and Psychosocial Barriers to Pre-exposure Prophylaxis in Zambia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PrEP Uptake
Keywords: stigma
prep
sex work
women
zambia
southern africa
community-based participatory research
community advisory board
Lead sponsor: Centre for Infectious Disease Research in Zambia
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: University of Washington
First posted: 2025-03-27
Enrollment: 299
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of adult WESW who are living or working within the catchment areas of two community hubs located within urban Lusaka. Based on CIDRZ's prior published work, we anticipate that the study population will be comprised largely (63%) of younger women (18 - 29 years old).

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

Eligibility criteria: 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:

* Exclusion criteria: (1) do not identify as a woman, (2) age \< 18 years old, (3) has not earned a significant amount of income from exchanging sex for money or goods or has earned for \< 3 months, (4) HIV-positive status or status is unknown or ineligible for PrEP, (5) planning to transfer care to another site within the next 30 days, (6) unable to speak English or ChiNyanja or IchiBemba and (7) not willing or able to provide written informed consent

Primary outcomes:
measure: PrEP initiation (#/% ever taken PrEP)
timeFrame: 3 months
measure: PrEP Persistence (#/ % eligible refills obtained until first discontinuation)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research Zambia
Study officials:
affiliation: University of Washington
name: Ramya Kumar, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: