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| Name | Class |
|---|---|
| Mildmay Uganda Limited | OTHER |
| Makerere University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced PrEP provision | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
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Inclusion Criteria for PrEP initiation:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura M Bogart, PhD | RAND | Principal Investigator |
| Rhoda K Wanyenze, MBChB,PhD,MPH | Makerere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makerere University School of Public Health | Kampala | Uganda | ||||
| Mildmay Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39028385 | Derived | 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. |
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This study was conducted at two mainland fisherfolk landing sites in Wakiso District, Uganda. We collected healthcare facility data on HIV testing and PrEP eligibility 6-months before and during the intervention (4-9/21 & 9/21-2/22, respectively) in the intervention community, and during the intervention in the comparison community; and medical records for de-identified client-level PrEP initiation and refill dates for all PrEP users who initiated before and during the intervention (4/21-8/22).
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Period, Intervention Site | At the intervention site during healthcare facility outreach events, all community members were offered the opportunity to attend intervention workshops where they learned basic facts about PrEP and were taught skills about how to advocate for PrEP in their community. Check-in reminder calls were conducted systematically with PrEP users. Healthcare facility staff encouraged PrEP initiators to select an adherence supporter. |
| FG001 | Pre-intervention Period, Intervention Site | Prior to the intervention period in the intervention community, healthcare facility staff provided PrEP through outreach events and in local healthcare facilities according to the standard of care. |
| FG002 | Intervention Period, Comparison Site | During the intervention period in the comparison community, healthcare facility staff provided PrEP through outreach events and in local healthcare facilities according to the standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Period, Intervention Site | At the intervention site during healthcare facility outreach events, PrEP initiators will be offered guidance on selecting an adherence supporter during PrEP initiation. All outreach event attendees at the events will be offered the opportunity to attend the intervention workshops. Check-in reminder calls will be conducted systematically with PrEP users. Enhanced PrEP provision: The intervention will train health care providers to facilitate workshops at outreach events where attendees can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter. Check-in reminder calls will be conducted systematically with PrEP users. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data were obtained from medical records for PrEP users |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All individuals eligible for PrEP are given the option of initiating (1) or declining (0). | Posted | Count of Participants | Participants | Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Period, Intervention Site | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Bogart | RAND | 3103930411 | lbogart@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2024 | Mar 8, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2021 | Apr 24, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| Kampala |
| Uganda |
| BG001 | Pre-intervention Period, Intervention Site | 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. |
| BG002 | Intervention Period, Comparison Site | At the control site, healthcare facility staff will continue to provide PrEP according to the standard of care. |
| BG003 | Total | Total of all reporting groups |
We only had IRB approval to collect demographic data for those who initiated PrEP
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | We only had IRB approval to collect demographic data for those who initiated PrEP | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Pre-Intervention Period, Intervention Site | Prior to the intervention period in the same community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care. |
| OG002 | Intervention Period, Comparison Site | During the intervention period in the control community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care. |
|
|
|
| Primary | Number of Participants Who Persisted On PrEP After Initiation | Percentage of PrEP users who are still on PrEP at 6 months post-initiation | Analysis of PrEP persistence is restricted to those who initiated PrEP | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | 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) | Analysis of PrEP coverage is restricted to those who initiated PrEP | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 0 |
| 192 |
| 0 |
| 192 |
| 0 |
| 192 |
| EG001 | Pre-Intervention Period, Intervention Site | Prior to the intervention period in the same community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care. | 0 | 120 | 0 | 120 | 0 | 120 |
| EG002 | Intervention Period, Comparison Site | During the intervention period in the control community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care. | 0 | 426 | 0 | 426 | 0 | 426 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Male |
|
| Odds Ratio (OR) |
| 1.78 |
| 2-Sided |
| 95 |
| 1.26 |
| 2.52 |
| Superiority |
| <.0001 |
| Odds Ratio (OR) |
| 0.24 |
| 2-Sided |
| 95 |
| 0.16 |
| 0.34 |
| Superiority |