HIV
Conditions
Keywords
PrEP, Fisherfolk, Uganda, HIV/AIDS
Brief 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.
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: 1. 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. 2. 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. 3. 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.
Interventions
BEHAVIORALEnhanced PrEP provision
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.
Sponsors
Mildmay Uganda Limited
Makerere University
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for PrEP initiation: * Tests HIV-negative at a healthcare outreach/HIV testing event in one of the two selected fishing communities and is PrEP-eligible
Exclusion criteria
* Not meeting the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With PrEP Initiation | 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 | 6 months | Percentage of PrEP users who are still on PrEP at 6 months post-initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Maintained PrEP Prescriptions Over 6 Months | 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) |
Countries
Uganda
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 199 |
| 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. | 142 |
| Intervention Period, Comparison Site At the control site, healthcare facility staff will continue to provide PrEP according to the standard of care. | 544 |
| Total | 885 |
Baseline characteristics
| Characteristic | Intervention Period, Intervention Site | Pre-intervention Period, Intervention Site | Intervention Period, Comparison Site | Total |
|---|---|---|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 9.5 | 29.1 years STANDARD_DEVIATION 7.9 | 27.3 years STANDARD_DEVIATION 5.3 | 28.6 years STANDARD_DEVIATION 7.2 |
| Race/Ethnicity, Customized Black African | 199 Participants | 142 Participants | 544 Participants | 885 Participants |
| Sex: Female, Male Female | 105 Participants | 49 Participants | 160 Participants | 314 Participants |
| Sex: Female, Male Male | 87 Participants | 71 Participants | 266 Participants | 424 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 192 | 0 / 120 | 0 / 426 |
| other Total, other adverse events | 0 / 192 | 0 / 120 | 0 / 426 |
| serious Total, serious adverse events | 0 / 192 | 0 / 120 | 0 / 426 |
Outcome results
Primary
Number of Participants Who Persisted On PrEP After Initiation
Percentage of PrEP users who are still on PrEP at 6 months post-initiation
Time frame: 6 months
Population: Analysis of PrEP persistence is restricted to those who initiated PrEP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Period, Intervention Site | Number of Participants Who Persisted On PrEP After Initiation | 92 Participants |
| Pre-Intervention Period, Intervention Site | Number of Participants Who Persisted On PrEP After Initiation | 8 Participants |
| Intervention Period, Comparison Site | Number of Participants Who Persisted On PrEP After Initiation | 145 Participants |
p-value: <0.000195% CI: [5.96, 27.85]Regression, Logistic
p-value: 0.00195% CI: [1.26, 2.52]Regression, Logistic
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
Time frame: Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible
Population: All individuals eligible for PrEP are given the option of initiating (1) or declining (0).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Period, Intervention Site | Number of Participants With PrEP Initiation | 192 Participants |
| Pre-Intervention Period, Intervention Site | Number of Participants With PrEP Initiation | 120 Participants |
| Intervention Period, Comparison Site | Number of Participants With PrEP Initiation | 426 Participants |
p-value: <0.000195% CI: [2.08, 12.13]Regression, Logistic
p-value: <0.000195% CI: [3.48, 16.59]Regression, Logistic
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)
Time frame: 6 months
Population: Analysis of PrEP coverage is restricted to those who initiated PrEP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Period, Intervention Site | Number of Participants Who Maintained PrEP Prescriptions Over 6 Months | 69 Participants |
| Pre-Intervention Period, Intervention Site | Number of Participants Who Maintained PrEP Prescriptions Over 6 Months | 0 Participants |
| Intervention Period, Comparison Site | Number of Participants Who Maintained PrEP Prescriptions Over 6 Months | 300 Participants |
p-value: <0.0001Fisher Exact
p-value: <0.000195% CI: [0.16, 0.34]Regression, Logistic