NCT06898112

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 11, 2025

Last Update Submit

March 25, 2025

Conditions

PrEP Uptake

Keywords

stigmaprepsex workwomenzambiasouthern africacommunity-based participatory researchcommunity advisory board

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

PrEP initiators

women who initiate on PrEP

Drug: PrEP

PrEP refusers

women who refuse PrEP

Interventions

PrEPDRUG

oral PrEP

PrEP initiators

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscis or trans-gender women self identified
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Infectious Disease Research Zambia

Lusaka, Zambia

Location

Related Links

MeSH Terms

Conditions

Social StigmaSex Work

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorSexual Behavior

Study Officials

  • Ramya Kumar, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 27, 2025

Study Start

July 18, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

ZA(1)