HIV Clinical Trial
Official title:
Parrying the Pitfalls of PrEP: Preventing Premature PrEP Discontinuation and STIs Among MSM
The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-demand oral PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP and injectable PrEP.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Male at birth - Self-identify as Cisgender Male - Ages 18-45 years - =1 male anal sex partner in the 12 months before the baseline interview - Live in the Atlanta MSA - Owns cell phone with data service - Willing to download a health-related app to their cell phone as part of the research study - Able to provide = 2 means of contact - Not currently enrolled in another HIV prevention clinical trial - Confirmed HIV-negative at baseline visit Exclusion Criteria: - Female at birth - Do not self-identify as Cisgender Male - Individuals < 18 years of age or > 45 years of age - HIV positive status - No male anal sex partner in the 12 months before the baseline interview - Does not own mobile phone with data service - Not willing to download a health-related app to their cell phone as part of the research study - Live outside the metro Atlanta MSA and/or planning to move from Atlanta area in the next 2 years - Currently enrolled in an HIV prevention or treatment clinical trial - Adults unable to consent - Individuals who are not yet adults (infants, children, teenagers) - Pregnant women - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | PRISM Research Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of men who discontinue daily oral PrEP | MSM taking daily oral PrEP will complete monthly screener surveys delivered through study app to assess for PrEP stop intentions. After early identification, they will receive Motivational Interviewing (MI) to avoid discontinuation. Participants that discontinue PrEP will be measured. | 24 month post intervention | |
Primary | Number of men who initiate on-demand oral PrEP | MSM who decline daily oral PrEP will be prescribed TDF/FTC fixed dose combination, 2 doses 2-24 hrs before sex and single dose 24 and 48 hours after first dose. | 24 month post intervention | |
Primary | Number of men who initiate long-acting injectable PrEP | Number of men who are not interested in daily oral PrEP or on-demand oral PrEP will be offered Long-acting injectable PrEP through referral to outside providers. | 24 month post intervention | |
Primary | Change in number of STI diagnoses from baseline at 12 and 24 months | All men in cohort will be evaluated for STI diagnoses after 12 and 24 month post intervention. | Baseline, 12 and 24 months post intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06162897 -
Case Management Dyad
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT02528773 -
Efficacy of ART to Interrupt HIV Transmission Networks
|
||
Recruiting |
NCT05454839 -
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
|
||
Recruiting |
NCT05322629 -
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
|
N/A | |
Completed |
NCT02579135 -
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
|
N/A | |
Active, not recruiting |
NCT01790373 -
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
|
N/A | |
Not yet recruiting |
NCT06044792 -
The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
|
||
Completed |
NCT04039217 -
Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM
|
Phase 4 | |
Active, not recruiting |
NCT04519970 -
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
|
N/A | |
Completed |
NCT04124536 -
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
|
N/A | |
Recruiting |
NCT05599581 -
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT02758093 -
Speed of Processing Training in Adults With HIV
|
N/A | |
Completed |
NCT02500446 -
Dolutegravir Impact on Residual Replication
|
Phase 4 | |
Completed |
NCT03805451 -
Life Steps for PrEP for Youth
|
N/A | |
Active, not recruiting |
NCT03902431 -
Translating the ABCS Into HIV Care
|
N/A | |
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 |