ClinicalTrials.gg
CompletedNCT06898112WiSSPrUpdated Sep 25, 2026

Mixed-methods Protocol for the WiSSPr Study

An observational study in PrEP Uptake, sponsored by Centre for Infectious Disease Research in Zambia. Completed at 1 site in Zambia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Centre for Infectious Disease Research in Zambia · Observational

Updated Sep 25, 2026Eligibility revisedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
299
Ages
18 Years and older
Sex
Female
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Study 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).

Read the 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). The study 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). The study 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. The study seeks 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

02

Conditions studied

  • PrEP Uptake

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Keywords

  • stigma
  • prep
  • sex work
  • women
  • zambia
  • southern africa
  • community-based participatory research
  • community advisory board
03

In context

Social Stigma

266 studies on the registry are indexed under Social Stigma; 66 are open to participants now.

This study's enrollment of 299 is above the median of 260 across 44 observational studies indexed under Social Stigma.

Browse Social Stigma studies →

Lead sponsor

Centre for Infectious Disease Research in Zambia is the lead sponsor of 41 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 25, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
Female
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participants must meet all of the following criteria:

  • Identify as a cisgender or transgender woman.
  • Be 18 years of age or older.
  • Earn a significant amount of income from exchanging sex for money or goods within the last 3 months.
  • Be -negative and eligible for PrEP according to national guidelines.
  • Not be planning to transfer care to another site within the next 30 days.
  • Speak English, ChiNyanja, or IchiBemba.
  • Be willing and able to provide written .

Exclusion criteria

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria:

  • Do not identify as a woman.
  • Are under 18 years of age.
  • Have not earned a significant amount of income from exchanging sex for money or goods, or have done so for less than 3 months.
  • Are -positive, have an unknown HIV status, or are ineligible for PrEP.
  • Are planning to transfer care to another site within the next 30 days.
  • Are unable to speak English, ChiNyanja, or IchiBemba.
  • Are unwilling or unable to provide written .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
299 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • PrEP initiators

    women who initiate on PrEP

    Drug: PrEP

  • PrEP refusers

    women who refuse PrEP

Interventions

  • DrugPrEP

    oral PrEP

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What researchers measure

Primary outcomes

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

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

    Time frame: 3 months

  2. 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

    Time frame: 3 months

07

Study locations

1 site
  • Centre for Infectious Disease Research Zambia
    Lusaka, Zambia
08

References and documents

Related links

Individual participant data

Plan to share: No — 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.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
8 inclusion criteria added, 1 removed; 8 exclusion criteria added, 1 removed
What changed in the criteria
Inclusion criteria
  • RemovedInclusion 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
  • AddedParticipants must meet all of the following criteria:
  • AddedIdentify as a cisgender or transgender woman.
  • AddedBe 18 years of age or older.
  • AddedEarn a significant amount of income from exchanging sex for money or goods within the last 3 months.
  • AddedBe HIV-negative and eligible for PrEP according to national guidelines.
  • AddedNot be planning to transfer care to another site within the next 30 days.
  • AddedSpeak English, ChiNyanja, or IchiBemba.
  • AddedBe willing and able to provide written informed consent.
Exclusion criteria
  • RemovedExclusion 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
  • AddedParticipants will be excluded if they meet any of the following criteria:
  • AddedDo not identify as a woman.
  • AddedAre under 18 years of age.
  • AddedHave not earned a significant amount of income from exchanging sex for money or goods, or have done so for less than 3 months.
  • AddedAre HIV-positive, have an unknown HIV status, or are ineligible for PrEP.
  • AddedAre planning to transfer care to another site within the next 30 days.
  • AddedAre unable to speak English, ChiNyanja, or IchiBemba.
  • AddedAre unwilling or unable to provide written informed consent.
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Eligibility 8 inclusion criteria added, 1 removed; 8 exclusion criteria added, 1 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedInclusion 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
    • AddedParticipants must meet all of the following criteria:
    • AddedIdentify as a cisgender or transgender woman.
    • AddedBe 18 years of age or older.
    • AddedEarn a significant amount of income from exchanging sex for money or goods within the last 3 months.
    • AddedBe HIV-negative and eligible for PrEP according to national guidelines.
    • AddedNot be planning to transfer care to another site within the next 30 days.
    • AddedSpeak English, ChiNyanja, or IchiBemba.
    • AddedBe willing and able to provide written informed consent.
    Exclusion criteria
    • RemovedExclusion 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
    • AddedParticipants will be excluded if they meet any of the following criteria:
    • AddedDo not identify as a woman.
    • AddedAre under 18 years of age.
    • AddedHave not earned a significant amount of income from exchanging sex for money or goods, or have done so for less than 3 months.
    • AddedAre HIV-positive, have an unknown HIV status, or are ineligible for PrEP.
    • AddedAre planning to transfer care to another site within the next 30 days.
    • AddedAre unable to speak English, ChiNyanja, or IchiBemba.
    • AddedAre unwilling or unable to provide written informed consent.
    + 4 other changes: index terms, verification date, oversight details and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT06898112
Lead sponsor
Centre for Infectious Disease Research in Zambia
Responsible party
Sponsor
First posted
Mar 27, 2025
Start date
Jul 18, 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Last update
Sep 25, 2026

Study contacts

Ramya Kumar, PhD, MPH
principal investigator · University of Washington

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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