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NCT Number: NCT06898112

Mixed-methods Protocol for the WiSSPr Study

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre for Infectious Disease Research Zambia

Lusaka, Zambia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrEP

Drug

oral PrEP

Primary outcomes

  1. PrEP initiation (#/% ever taken PrEP)

    Time frame: 3 months

    PrEP initiation (Number or percentage of Women Engaging in Sex Work (WESW) initiating on PrEP)

  2. PrEP Persistence (#/ % eligible refills obtained until first discontinuation)

    Time frame: 3 months

    PrEP persistence. Number or percentage of women engaging in sex work with high levels of stigma who will persist on PrEP

Sponsors and collaborators

Lead sponsor

Centre for Infectious Disease Research in Zambia

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • University of Washington

Registry information

Official study title

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

Acronym: WiSSPr

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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