PrEP UptakeWiSSPrNCT06898112
Mixed-methods Protocol for the WiSSPr Study
An observational study of PrEP Uptake, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP Uptake
- What is being tested?
- PrEP
- Type of treatment
- Pill or oral medicine
- How many people
- 299 participants
- Where
- 1 siteZambia
- Study dates
- 18 Jul 2023to 31 Mar 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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 HIV-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 informed consent.
Who cannot join
- 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 HIV-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 informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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
- Conditions
- PrEP Uptake
- Being tested
- PrEP
- Keywords
- stigma, prep, sex work, women, zambia, southern africa, community-based participatory research, community advisory board
- Medical subject headings
- Social Stigma, Sex Work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPDrug
oral PrEP
| Study group | Role | What they receive |
|---|---|---|
| PrEP initiators | women who initiate on PrEP Receives: Drug: PrEP | |
| PrEP refusers | women who refuse PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP initiation (#/% ever taken PrEP)
PrEP initiation (Number or percentage of Women Engaging in Sex Work (WESW) initiating on PrEP)
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start18 Jul 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP UptakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of Washington
- Responsible party
- Sponsor
- Investigators
- Ramya Kumar, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898112
- Sponsor's protocol ID
- UJMT Fogarty Fellowship 2023
- Other IDs
- D43TW009340
- Acronym
- WiSSPr
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed-methods Protocol for the WiSSPr Study: Women in Sex Work, Stigma and Psychosocial Barriers to Pre-exposure Prophylaxis in Zambia
- ClinicalTrials.gov ID
- NCT06898112
- Acronym / sponsor ID
- WiSSPr / UJMT Fogarty Fellowship 2023
- Conditions
- PrEP Uptake
- Keywords
- stigma, prep, sex work, women, zambia, southern africa, community-based participatory research, community advisory board
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of Washington
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP initiators | – | Drug: PrEPwomen who initiate on PrEP |
| PrEP refusers | – | –women who refuse PrEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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 HIV-negative and eligible for PrEP according to national guidelines.
- Not be planning to transfer care to another site within the next 30 days.
Key exclusion criteria (8 listed)
- 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 HIV-positive, have an unknown HIV status, or are ineligible for PrEP.
- Are planning to transfer care to another site within the next 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEPoral PrEP | Drug | PrEP initiators |
Primary outcome
PrEP initiation (#/% ever taken PrEP)
Time frame: 3 months
PrEP initiation (Number or percentage of Women Engaging in Sex Work (WESW) initiating on PrEP)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Protocol paperLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramya Kumar, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PrEP Uptake, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP initiation (#/% ever taken PrEP) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.