Mixed-methods Protocol for the WiSSPr Study (WiSSPr)

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

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).

Study Overview

• Status: Completed
• Conditions: PrEP Uptake
• Intervention / Treatment: Drug: PrEP

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

• Study Type: Observational
• Enrollment (Actual): 299

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • Centre for Infectious Disease Research Zambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PrEP initiators; women who initiate on PrEP	Drug: PrEP; oral PrEP
PrEP refusers; women who refuse PrEP

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre for Infectious Disease Research in Zambia
• Collaborators: University of Washington; Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Ramya Kumar, PhD, MPH, University of Washington

Publications and helpful links

Helpful Links

• Protocol paper

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: stigma; women; community-based participatory research; prep; sex work; community advisory board; zambia; southern africa
• Other Study ID Numbers: UJMT Fogarty Fellowship 2023; D43TW009340 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Vulnerable population of sex workers in a country where sex work is largely criminalized, and there is a risk of harm if the data is identifiable even with common identifiers like name is removed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No