HIV Infection, Sexually Transmitted Infection
Conditions
Keywords
Human Immunodeficiency Virus (HIV), Sexually Transmitted Infection (STI), Pre-Exposure Prophylaxis (PrEP), Post-Exposure Prophylaxis (PEP), Integrated Strategy, Young Men, Doxycycline for STI Post-Exposure Prophylaxis (Doxy-PEP), Chlamydia Trachomatis (CT), Neisseria Gonorrhea (NG), Hepatitis B (HBV), Mobile Health Tools (mHealth), MyPrEP + PrEPmate + PrEPsmart Tools (3P)
Brief summary
Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men
Detailed description
This study will test a suite of mHealth tools to increase HIV pre-exposure prophylaxis (PrEP) uptake and adherence among young men in communities most affected by the HIV epidemic and evaluate the uptake, adherence, and acceptability of doxycycline for sexually transmitted infection (STI) post-exposure prophylaxis (doxy-PEP).
Interventions
DRUGHIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
DRUGSTI PEP - Doxycycline as Doxy-PEP
Doxycycline as doxy-PEP for STI prevention
BEHAVIORAL3P mHealth package
Suite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making
BEHAVIORALHandout about HIV PrEP options available at the site
Handout about HIV PrEP options available at the site
BEHAVIORALStandard-of-care HIV PrEP counseling from qualified study staff
Standard-of-care HIV PrEP counseling from qualified study staff
Sponsors
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Gilead Sciences
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All participants will be offered HIV PrEP and doxy-PEP. Participants will be randomized 1:1 to receive either the 3P mHealth package (3P: MyPrEP \+ PrEPmate + PrEPsmart tools) or standard-of-care services arm.
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men ages 18 - 29 years 2. Men who are in communities most affected by the HIV epidemic 3. Willing and able to provide informed consent 4. Reports having anal sex with men in the last 6 months 5. Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months: 1. Any condomless anal sex with a man; not including within a monogamous relationship with an HIV-negative partner or an HIV-positive partner who is virally suppressed 2. Reporting 2 or more male partners, regardless of condom use 3. Reporting gonorrhea, chlamydia, or syphilis diagnosis 4. Any stimulant use (e.g., cocaine, amphetamines) 6. Not on PrEP within the past 3 months due to participant choice 7. Interested in learning more about PrEP or starting PrEP 8. No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm 9. Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages 10. Must not share the mobile phone used for their participation in the study 11. Able to read and write
Exclusion criteria
1. Participated in HPTN 113-01 2. Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083 3. Plans to move away from the study area within the next year 4. Currently on doxycycline for STI PEP 5. Has ever used CAB-LA or other long-acting PrEP agent 6. Tetracycline allergy 7. Prior diagnosis of HIV infection 8. Reactive HIV rapid test at Screening or reactive HIV Ag/Ab rapid test at Enrollment, regardless of subsequent HIV test results 9. Any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the efficacy of the 3P mHealth package on PrEP uptake among participants | 52 weeks | PrEP uptake is defined as the proportion of enrolled participants who elect to initiate PrEP (with a documented PrEP dispensation by the site) at any time during the 52 weeks of follow-up. Participants who did not initiate PrEP before loss to follow-up will be classified as non-initiators. PrEP uptake will be assessed at Week 52 for each study arm with 95% confidence limits computed using the binomial distribution. A logistic regression model will be used to compare PrEP uptake between the study arms. |
| To determine the efficacy of the 3P mHealth package on PrEP adherence among participants | Weeks 20, 36, and 52 | PrEP adherence is assessed at Weeks 20, 36 and 52 through biomedical testing for oral PrEP regimens and documentation of CAB-LA injection for CAB-LA. Adherence measures are described in Section 8.7. Participants on oral PrEP missing an assessment visit and with no PrEP dispensed at their most recent visit will be considered non-adherent. Also, participants who have not yet initiated PrEP at a visit will be considered non-adherent at that visit. The average PrEP adherence at a visit will be computed as the proportion of participants who are determined to be adherent at that visit by study arm. The associated 95% confidence limits will be computed using the binomial distribution. Generalized estimating equations (GEE) with a logit link function will be used to examine differences in adherence proportions between the 3P and Control arms at Weeks 20, 36 and 52, while accounting for potential correlation between PrEP adherence measures over time for each participant. |
| To assess doxycycline PEP uptake and associated factors | Week 52 | doxy-PEP uptake is defined as the proportion of participants dispensed doxy-PEP during the 52 weeks of study follow-up period. doxy-PEP uptake will be computed with 95% confidence limits at Week 52. Multivariable logistic regression models will be used to assess association between doxy-PEP uptake and factors including study group, demographic and behavioral characteristics. |
| To assess doxycycline PEP use and associated factors | Weeks 20, 36, and 52 | doxy-PEP use will be assessed at Weeks 20, 36 and 52. Doxy-PEP use at an assessment visit will be computed as the proportion of participants reporting use following sex acts, reported at that visit. The corresponding 95% confidence limits will be computed based on the binomial distribution. Multivariable GEE models will be used to investigate possible associations between doxy-PEP use and factors including study group, demographic and behavioral characteristics. |
| To assess doxycycline PEP acceptability and associated factors | Week 52 | Descriptive statistics will be used to summarize doxy-PEP acceptability. Multivariable generalized linear models (with a link function that is appropriate to the scale of the measure for doxy-PEP acceptability) will be used to investigate associations between doxy-PEP acceptability and factors including study group, sociodemographic, and behavioral characteristics. |
| To assess the incidence of HIV infections among participants choosing to use CAB-LA | Week 52 | Uptake of CAB-LA is defined as the proportion of participants choosing to initiate CAB-LA with a documented receipt of a CAB-LA injection during the study follow-up period. CAB-LA uptake will be computed with 95% confidence interval. Incidence of HIV infection between the date of CAB-LA initiation and the date of switch to oral PrEP (for participants switching from CAB-LA to oral PrEP) or end of follow-up (for participants staying on CAB-LA from initiation through the end of the follow-up period) will be computed with 95% confidence interval among participants choosing to use CAB-LA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the acceptability and use of the 3P mHealth package in the intervention arm by site | Week 52 | Descriptive statistics will be used to summarize the acceptability and use of the 3P mHealth package in the intervention arm by site. |
| To compare the frequency, directionality, and reasons for PrEP regimen choice and switching, between arms | Week 52 | Descriptive statistics will be used to summarize the frequency, directionality, and reasons for PrEP regimen choice and switching by arm. Generalized linear models will be used to assess differences in these descriptive summaries between the study arms. Reasons for PrEP regimen choice and switching obtained from qualitative interview data will be listed by arm. |
| To evaluate demographic, behavioral, and attitudinal factors associated with choice of PrEP regimen | Week 52 | Multivariable logistic regression models will be used to separately assess associations between each PrEP regimen choice and demographic, behavioral, and attitudinal factors. |
| To determine the efficacy of the 3P mHealth package on prevention-effective adherence | Weeks 20, 36, and 52 | * The proportion of enrolled participants with incident STI infection will be computed with 95% confidence limits at Weeks 20, 36 and 52 by study arm. * The proportion of enrolled participants with incident HIV infection will be computed at Weeks 20, 36 and 52 by study arm. * The proportion of enrolled participants reporting HIV risk based on self-reported sexual behavior and HIV status of sexual partner will be computed at Weeks 20, 36 and 52 by study arm. * The proportion of enrolled participants who are determined to be PrEP adherent and potentially at HIV risk (based on incident STI, self-reported sexual behavior and HIV status of partners) will be computed with 95% confidence limits at Weeks 20, 36 and 52 by study arm. GEE models with a logit link function will be used to compare the proportions between the study arms |
Countries
Argentina, Brazil, Peru, United States
Contacts
CONTACTKailazarid Gomez-Feliciano, MPM
CONTACTMichelle Robinson
STUDY_CHAIRSusan Buchbinder, MD
San Francisco Department of Public Health and University of California San Francisco
STUDY_CHAIRJorge Gallardo-Cartagena, MD
Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales
STUDY_CHAIRThiago Torres, MD
Instituto Nacional de Infectología Evandro Chagas
Outcome results
None listed