Prevention
Conditions
Keywords
PrEP, Prevention, Male Sex Workers (MSW)
Brief summary
PrEPare for Work is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).
Detailed description
The PrEPare for Work package includes two behavioral intervention components: 1. Strengths-based case management for PrEP initiation, and 2. Counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use. Stage 1: MSW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic. Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the PrEPare for Work adherence intervention or standard of care comparison condition.
Interventions
BEHAVIORALPrEPare for Work: Strength Based Case Management (Stage 1)
Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
BEHAVIORALPrEPare for Work: Adherence Training and Counseling (Stage 2)
Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.
Sponsors
The Miriam Hospital
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
In Stage 1, individuals will be randomized (1:1) to receive the experimental PrEP navigation or standard of care. Among those who uptake PrEP in Stage 1, we will randomize those participants in Stage 2 (1:1) to receive the experimental adherence counseling or standard of care.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Biological male at birth and current male gender identity * Exchanged sex for money or drugs with another man in the past 3 months * Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months * HIV uninfected by antibody test\* Stage 2 * Able to understand and speak English (for consent and counseling) * Mental competency to provide voluntary informed consent * Lives in the New England area * Willing to initiate PrEP
Exclusion criteria
* Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate * HIV Positive at baseline * Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate \< 50) \*Stage 2 * History of or current medical conditions that would preclude taking Truvada for PrEP \*Stage 2 * Currently taking Truvada for PrEP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic | 2-month post Stage 1 randomization | Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records |
| Number of Participants Who Initiated PrEP | 2-month post Stage 1 randomization | Initial prescription from provider filled and shown to study staff |
| Number of Participants Reporting Optimal PrEP Adherence | 6-months post Stage 2 randomization | Self-reporting missing 0 PrEP pills in the past week |
Countries
United States
Participant flow
Pre-assignment details
One participant was partially enrolled and never completed enrollment. Only participants who completed Stage 1 AND who initiated PrEP were included in Stage 2.
Participants by arm
| Arm | Count |
|---|---|
| Strength Based Case Management Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. | 55 |
| Standard of Care:Stage 1 Stage 1: Referral to The Miriam Hospital PrEP Clinic. | 55 |
| PrEP Adherence Training and Counseling Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.
PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. | 0 |
| Standard of Care: Stage 2 Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test. | 0 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Stage 1: PrEP Uptake | Death | 1 | 0 | 0 | 0 |
| Stage 1: PrEP Uptake | Incarcerated | 3 | 1 | 0 | 0 |
| Stage 1: PrEP Uptake | Lost to Follow-up | 6 | 5 | 0 | 0 |
| Stage 1: PrEP Uptake | Withdrawal by Subject | 1 | 4 | 0 | 0 |
| Stage 2: PrEP Adherence | Incarcerated | 0 | 0 | 2 | 0 |
| Stage 2: PrEP Adherence | Lost to Follow-up | 0 | 0 | 3 | 2 |
| Stage 2: PrEP Adherence | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Strength Based Case Management | Standard of Care:Stage 1 | Total |
|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 7.8 | 34.6 years STANDARD_DEVIATION 9.2 | 34.2 years STANDARD_DEVIATION 8.5 |
| PrEP Use Self-Efficacy | 7.1 units on a scale STANDARD_DEVIATION 3.2 | 7.7 units on a scale STANDARD_DEVIATION 2.1 | 7.4 units on a scale STANDARD_DEVIATION 2.7 |
| Race/Ethnicity, Customized Black, non-Hispanic | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 15 Participants | 9 Participants | 24 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 27 Participants | 35 Participants | 62 Participants |
| Region of Enrollment United States | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 55 Participants | 55 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 55 | 2 / 55 | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 0 / 55 | 0 / 55 | 3 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 | 0 / 17 | 0 / 18 |
Outcome results
Primary
Number of Participants Reporting Optimal PrEP Adherence
Self-reporting missing 0 PrEP pills in the past week
Time frame: 6-months post Stage 2 randomization
Population: Per study design, PrEP adherence was only assessed in Stage 2 (and among Stage 2 participants); Additionally, because this was based on self-report, PrEP adherence was only assessed among those with follow up data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strength Based Case Management | Number of Participants Reporting Optimal PrEP Adherence | 5 Participants |
| Standard of Care:Stage 1 | Number of Participants Reporting Optimal PrEP Adherence | 5 Participants |
Primary
Number of Participants Who Initiated PrEP
Initial prescription from provider filled and shown to study staff
Time frame: 2-month post Stage 1 randomization
Population: Per study design, PrEP initiation was only assessed in Stage 1; Additionally, because this required proof of prescription, we excluded those who were loss to follow up for Stage 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strength Based Case Management | Number of Participants Who Initiated PrEP | 26 Participants |
| Standard of Care:Stage 1 | Number of Participants Who Initiated PrEP | 9 Participants |
Primary
Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic
Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records
Time frame: 2-month post Stage 1 randomization
Population: Per study design, linkage to PrEP care was only assessed in Stage 1; Additionally, because this was based on medical records we could include anyone that was not withdrawn or incarcerated or had died (n=5 in each arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strength Based Case Management | Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic | 30 Participants |
| Standard of Care:Stage 1 | Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic | 13 Participants |