Sexually Transmitted InfectionZETRANCT03203200
A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers
A study testing ZETRA cognitive behavioral structural in people with Sexually Transmitted Infection, run by University of California, San Francisco at 1 site in Uganda.
Trial summary
This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infection
- What is being tested?
- ZETRA cognitive behavioral structural
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteUganda
- Study dates
- 24 Aug 2015to 31 Oct 2021
- Phase
- Interventional
- 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 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV-uninfected women, aged 15-24 years, being sexually active and having engaged in any form of transactional sex at least once in the last 3 months, agreeing to participate in all intervention sessions and to all study procedures and interviews planned over 18 months of follow-up.
Who cannot join
- presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior
This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.
- Conditions
- Sexually Transmitted Infection
- Being tested
- ZETRA cognitive behavioral structural
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZETRA cognitive behavioral structuralBehavioural
ZETRA cognitive behavioral structural
| Study group | Role | What they receive |
|---|---|---|
| health literacy and technology skill building | Experimental | ZETRA cognitive behavioral and structural Receives: Behavioral: ZETRA cognitive behavioral structural |
| Standard Counselling | No intervention | Standard of care prevention counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected Sex
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start24 Aug 2015
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, MRC/UVRI and LSHTM Uganda Research Unit, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Rachel King, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203200
- Sponsor's protocol ID
- R01 HD085805-01
- Other IDs
- 5R01MH109337-02
- Acronym
- ZETRA
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2017
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
King R, Muhanguzi E, Nakitto M, Mirembe M, Kasujja FX, Bagiire D, Seeley J. Mobility study of young women who exchange sex for money or commodities using Google Maps and qualitative methods in Kampala, Uganda. BMJ Open. 2021 May 19;11(5):e043078. doi: 10.1136/bmjopen-2020-043078.
PubMed 34011583
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior
- ClinicalTrials.gov ID
- NCT03203200
- Acronym / sponsor ID
- ZETRA / R01 HD085805-01
- Conditions
- Sexually Transmitted Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Connecticut, MRC/UVRI and LSHTM Uganda Research Unit, National Institute of Mental Health (NIMH)
- Study start
- 24 Aug 2015 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 29 Jun 2017 (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.
This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health literacy and technology skill building | Experimental | Behavioral: ZETRA cognitive behavioral structuralZETRA cognitive behavioral and structural |
| Standard Counselling | No intervention | –Standard of care prevention counselling |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- HIV-uninfected women, aged 15-24 years, being sexually active and having engaged in any form of transactional sex at least once in the last 3 months, agreeing to participate in all intervention sessions and to all study procedures and interviews planned over 18 months of follow-up.
Key exclusion criteria (1 listed)
- presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection
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 |
|---|---|---|
| ZETRA cognitive behavioral structuralZETRA cognitive behavioral structural | Behavioural | health literacy and technology skill building |
Primary outcome
Unprotected Sex
Time frame: 18 months
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 16 Mar 2022.
- Derived from this study: PubMed 34011583King R, Muhanguzi E, Nakitto M, Mirembe M, Kasujja FX, Bagiire D, Seeley J. Mobility study of young women who exchange sex for money or commodities using Google Maps and qualitative methods in Kampala, Uganda. BMJ Open. 2021 May 19;11(5):e043078. doi: 10.1136/bmjopen-2020-043078.
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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.
Rachel King, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZETRA cognitive behavioral structural in people with Sexually Transmitted Infection, run by University of California, San Francisco at 1 site in Uganda.
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 1 inclusion and 1 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 16 Mar 2022. 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 Uganda. 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?
Unprotected Sex (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03203200, which also lists 1 linked publication.
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 16 Mar 2022.