HIVNCT05084716

Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk

A study testing Enhanced PrEP provision in people with HIV, run by RAND at 2 sites in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is a pilot test of enhancements to the standard of care for providing PrEP in Ugandan fishing communities. The specific aims are to conduct a mixed-methods study assessing enhancements to the standard of care for providing PrEP in fisherfolk communities in Lake Victoria, Uganda. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: Enhanced PrEP provision
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 885 participants
Where: 2 sitesUganda
Study dates: 24 Sep 2021to 1 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Tests HIV-negative at a healthcare outreach/HIV testing event in one of the two selected fishing communities and is PrEP-eligible

Who cannot join

Not meeting the inclusion criteria

Trial locations and contacts

2 sites in 1 country.

Uganda2 sites

Makerere University School of Public Health
Kampala
Mildmay Uganda
Kampala

Other trials in Uganda

About this study

Official title: PrEP Provision for Ugandan Fisherfolk

Read the detailed description

The study will take place at two landing sites at which PrEP is provided to fisherfolk through the Ugandan national PrEP program. The comparison site will receive the standard of care for PrEP provision. At the intervention site, the investigators will implement a three-pronged intervention:

During healthcare outreach events we will conduct PrEP workshops, in which people who want to know more about PrEP learn basic facts about PrEP and are taught skills about how to advocate for PrEP in their community.
Check-in Calls: To support PrEP adherence, healthcare workers will call PrEP users two weeks after initiation, and the week before refill events, to check in about any questions and to remind them of the next date and place to pick up refills. Calls after PrEP initiation will ask about side effects.
To support PrEP adherence, healthcare workers will encourage PrEP users to select an adherence supporter, who is a family member or friend to whom they disclose their PrEP use. The adherence supporter agrees to remind the PrEP user to adhere to PrEP and get refills. Healthcare workers will ask the PrEP user for the name and contact information for the adherence supporter, so that the adherence supporter can be contacted to remind them about refills, as well as if the PrEP user does not show up for a refill.

Conditions: HIV
Being tested: Enhanced PrEP provision
Keywords: PrEP, Fisherfolk, Uganda, HIV/AIDS
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced PrEP provisionBehavioural
At the intervention site during healthcare facility outreach events, all community members will be offered the opportunity to attend intervention workshops where they can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Check-in reminder calls will be conducted systematically with PrEP users. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter.

Study groups in NCT05084716
Study group	Role	What they receive
Intervention	Experimental	At the intervention site during healthcare facility outreach events, all community members will be offered the opportunity to attend intervention workshops where they can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Check-in reminder calls will be conducted systematically with PrEP users. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter. Receives: Behavioral: Enhanced PrEP provision
Pre-Intervention Standard of Care	No intervention	Prior to the intervention period in the intervention community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.
Comparison Community	No intervention	The comparison community will receive standard of care for PrEP provision.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With PrEP Initiation
Individuals who are eligible for PrEP (tested HIV-negative, aged 18 and older, in fisherfolk community) are asked by a healthcare provider whether they want to start taking PrEP
Measured: Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible
Number of Participants Who Persisted On PrEP After Initiation
Percentage of PrEP users who are still on PrEP at 6 months post-initiation
Measured: 6 months

Secondary outcomes (1)

Number of Participants Who Maintained PrEP Prescriptions Over 6 Months
Percentage of PrEP users with a PrEP medication possession ratio of at least 80% coverage by PrEP prescriptions over 6 months. (i.e., 144 of 180 days)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 20211 Dec 2023

First posted20 Oct 2021
Study start24 Sep 2021
Primary completion1 Dec 2023
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 885 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05084716
Sponsor's protocol ID: R34MH119924
Status last verified: Jul 2024
First submitted: 6 Oct 2021
Last updated: 13 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bogart LM, Musoke W, Mukama CS, Allupo S, Klein DJ, Sejjemba A, Mwima S, Kadama H, Mulebeke R, Pandey R, Wagner Z, Mukasa B, Wanyenze RK. Enhanced Oral Pre-exposure Prophylaxis (PrEP) Implementation for Ugandan Fisherfolk: Pilot Intervention Outcomes. AIDS Behav. 2024 Oct;28(10):3512-3524. doi: 10.1007/s10461-024-04432-w. Epub 2024 Jul 19.
PubMed 39028385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PrEP Provision for Ugandan Fisherfolk
ClinicalTrials.gov ID: NCT05084716
Acronym / sponsor ID: R34MH119924
Conditions: HIV
Keywords: PrEP, Fisherfolk, Uganda, HIV/AIDS
Study type: Interventional
Recruitment status: Completed
Enrolment: 885 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Mildmay Uganda Limited, Makerere University
Study start: 24 Sep 2021 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 20 Oct 2021 (actual)
Results: Posted 13 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

During healthcare outreach events we will conduct PrEP workshops, in which people who want to know more about PrEP learn basic facts about PrEP and are taught skills about how to advocate for PrEP in their community.
Check-in Calls: To support PrEP adherence, healthcare workers will call PrEP users two weeks after initiation, and the week before refill events, to check in about any questions and to remind them of the next date and place to pick up refills. Calls after PrEP initiation will ask about side effects.
To support PrEP adherence, healthcare workers will encourage PrEP users to select an adherence supporter, who is a family member or friend to whom they disclose their PrEP use. The adherence supporter agrees to remind the PrEP user to adhere to PrEP and get refills. Healthcare workers will ask the PrEP user for the name and contact information for the adherence supporter, so that the adherence supporter can be contacted to remind them about refills, as well as if the PrEP user does not show up for a refill.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Intervention	Experimental	Behavioral: Enhanced PrEP provisionAt the intervention site during healthcare facility outreach events, all community members will be offered the opportunity to attend intervention workshops where they can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Check-in reminder calls will be conducted systematically with PrEP users. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter.
Pre-Intervention Standard of Care	No intervention	–Prior to the intervention period in the intervention community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.
Comparison Community	No intervention	–The comparison community will receive standard of care for PrEP provision.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Tests HIV-negative at a healthcare outreach/HIV testing event in one of the two selected fishing communities and is PrEP-eligible

Key exclusion criteria (1 listed)

Not meeting the inclusion criteria

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
Enhanced PrEP provisionAt the intervention site during healthcare facility outreach events, all community members will be offered the opportunity to attend intervention workshops where they can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Check-in reminder calls will be conducted systematically with PrEP users. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter.	Behavioural	Intervention

Primary outcome

Number of Participants With PrEP Initiation
Time frame: Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible
Individuals who are eligible for PrEP (tested HIV-negative, aged 18 and older, in fisherfolk community) are asked by a healthcare provider whether they want to start taking PrEP
Number of Participants Who Persisted On PrEP After Initiation
Time frame: 6 months
Percentage of PrEP users who are still on PrEP at 6 months post-initiation

1 secondary outcome

Number of Participants Who Maintained PrEP Prescriptions Over 6 Months
Time frame: 6 months

Results and safety

Results posted to the registry on 13 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Period, Intervention Site	199	199
Pre-intervention Period, Intervention Site	142	142
Intervention Period, Comparison Site	544	544

Primary outcome: Number of Participants With PrEP Initiation

Time frame: Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible. Count of participants. Unit: Participants

Measure	Intervention Period, Intervention Site n = 199	Pre-Intervention Period, Intervention Site n = 142	Intervention Period, Comparison Site n = 544
Value	192	120	426

Intervention Period, Intervention Site vs Pre-Intervention Period, Intervention Site: Odds Ratio (OR): 5.03 (95% CI 2.08 to 12.13), p <.0001, Regression, Logistic
Intervention Period, Intervention Site vs Intervention Period, Comparison Site: Odds Ratio (OR): 7.60 (95% CI 3.48 to 16.59), p <.0001, Regression, Logistic

Population analysed: All individuals eligible for PrEP are given the option of initiating (1) or declining (0).

Primary outcome: Number of Participants Who Persisted On PrEP After Initiation

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Intervention Period, Intervention Site n = 192	Pre-Intervention Period, Intervention Site n = 120	Intervention Period, Comparison Site n = 426
Value	92	8	145

Intervention Period, Intervention Site vs Pre-Intervention Period, Intervention Site: Odds Ratio (OR): 12.88 (95% CI 5.96 to 27.85), p <.0001, Regression, Logistic
Intervention Period, Intervention Site vs Intervention Period, Comparison Site: Odds Ratio (OR): 1.78 (95% CI 1.26 to 2.52), p = .001, Regression, Logistic

Population analysed: Analysis of PrEP persistence is restricted to those who initiated PrEP

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Period, Intervention Site	0 of 192 (0%)	0 of 192 (0%)	0 of 192
Pre-Intervention Period, Intervention Site	0 of 120 (0%)	0 of 120 (0%)	0 of 120
Intervention Period, Comparison Site	0 of 426 (0%)	0 of 426 (0%)	0 of 426

Limitations and caveats (from the sponsor): The intervention and comparison communities were mismatched: the comparison community had a less mobile population and a healthcare center (and the intervention community did not), making refill access easier. In addition, pre-intervention PrEP refill data were not available for the comparison site. Thus, we present results for the pre vs. during intervention period comparison in the intervention community, and for the intervention vs. comparison communities during the intervention period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39028385Bogart LM, Musoke W, Mukama CS, Allupo S, Klein DJ, Sejjemba A, Mwima S, Kadama H, Mulebeke R, Pandey R, Wagner Z, Mukasa B, Wanyenze RK. Enhanced Oral Pre-exposure Prophylaxis (PrEP) Implementation for Ugandan Fisherfolk: Pilot Intervention Outcomes. AIDS Behav. 2024 Oct;28(10):3512-3524. doi: 10.1007/s10461-024-04432-w. Epub 2024 Jul 19.
Individual participant dataSharing planned: No

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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.

Laura M Bogart, PhD principal investigator

RAND

Rhoda K Wanyenze, MBChB,PhD,MPH principal investigator

Makerere University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced PrEP provision in people with HIV, run by RAND at 2 sites 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With PrEP Initiation (time frame: Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible). 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?

On the ClinicalTrials.gov record for NCT05084716, 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 13 Aug 2024.