Increasing PrEP Persistence for HIV Prevention

Not currently recruiting at 3 trial locations

Overseen By Lawrence C Long, PhD MCom

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Boston University

Must be taking: PrEP

Disqualifiers: PrEP status unknown, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help men who have sex with men (MSM) in South Africa adhere to their daily HIV prevention pill, known as PrEP (pre-exposure prophylaxis). Researchers are testing a new approach that uses reminders, commitment pledges, and planning prompts delivered via mobile phones to boost persistence. Participants will be divided into two groups: one receiving standard care and the other receiving the new intervention. The trial seeks men who are starting PrEP for the first time or haven't used it in the past year, have access to a mobile phone, and can give consent in English. As an unphased trial, this study offers participants the opportunity to contribute to innovative strategies that could improve health outcomes for MSM communities.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on starting PrEP for HIV prevention.

What prior data suggests that this intervention is safe for improving PrEP persistence?

Studies have shown that behavioral economics, a method to understand decision-making, can help individuals adhere to their PrEP medication routine. Research indicates that participants respond well to these methods. For instance, one study found that reminders and planning prompts increased the likelihood of participants taking their PrEP as needed.

Another study examined similar methods and found improved medication adherence during follow-up checks. Importantly, these methods did not cause significant negative effects, demonstrating that reminders and prompts are both effective and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to help people stick with their HIV prevention medication, PrEP, which is crucial for its effectiveness. While the standard approach mainly involves regular medical check-ups and counseling, this trial uses principles from behavioral economics to motivate high-risk individuals to consistently take their medication. By addressing the psychological and behavioral barriers to medication adherence, this intervention could significantly improve long-term health outcomes for those at risk of HIV.

What evidence suggests that this trial's intervention could improve PrEP persistence for HIV prevention?

This trial will compare usual care with a behavioral economics-informed intervention to improve PrEP persistence among high-risk men newly starting PrEP in South Africa. Research has shown that strategies from behavioral economics can help people take their HIV prevention medication, called PrEP, more consistently. Studies have found that reminders and planning prompts can increase medication adherence. Specifically, one study discovered that people who received a digital reminder had PrEP adherence rates over 83% during follow-ups, compared to lower rates in those without the reminder. This suggests that such interventions could help more people maintain their daily PrEP routine, potentially reducing HIV infections. ^{2 3 5 6 7}

Who Is on the Research Team?

Lawrence C Long, PhD MCom

Principal Investigator

Boston University School of Public Health,Global Health

Are You a Good Fit for This Trial?

This trial is for men who have sex with men (MSM) in South Africa, who are starting on PrEP to prevent HIV. Participants must be willing to receive text messages and complete questionnaires. There's no detailed exclusion criteria provided.

Inclusion Criteria

Access to a mobile phone

Willing and able to provide written informed consent in English

I am starting PrEP on the day I join the study.

Exclusion Criteria

PrEP status unknown

I have used PrEP in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Intervention

Participants complete a baseline questionnaire and are randomized to receive either standard care or a behavioral economics informed intervention. The intervention includes reminders, commitment pledges, and planning prompts delivered at the enrollment visit and through mobile phone reminders.

3 months

1 visit (in-person), multiple mobile interactions

Follow-up

Participants are monitored for PrEP persistence through routine medical record review, with primary endpoints at 3, 6, and 12 months.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PrEP Persistence

Trial Overview The study tests if reminders, commitment pledges, and planning prompts can help MSM continue taking PrEP consistently. Participants will either get the standard care or this new intervention through mobile phone texts after an initial visit.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

Participants randomized into this group will receive a behavioral economics informed intervention to improve persistence among amongst high risk men newly initiating PrEP in South Africa.

Group II: Control group Active Control 1 Intervention

Usual care for high risk men newly initiating PrEP in South Africa.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12324821/

A Community-led, Multicomponent HIV Prevention Strategy ... Preliminary data from August 2022 through January 2024 showed promising implementation and effectiveness outcomes. During that time, 113 ...

2. ajpmonline.org ajpmonline.org/article/S0749-3797(21)00358-5/fulltext

Pre-exposure Prophylaxis Uptake, Adherence, and ... Among participants who received the targeted iNSC discussion, 50% had sustained improvements in TFV levels, and 13% had ≥1 detectable TFV level. Only 1 of the 4 ...

3. medrxiv.org medrxiv.org/content/10.1101/2020.12.10.20247270v2.full-text

A Decision Analytics Model to Optimize Investment in ... Results From the base 15% PrEP coverage level, the three interventions could increase coverage to 27%, resulting in 12.3% of infections averted ...

4. link.springer.com link.springer.com/article/10.1007/s11904-022-00624-y

Using Behavioral Economics to Support PrEP Adherence ... We explored different behavioral economics (BE) mechanisms through which pre-exposure prophylaxis (PrEP) initiation and adherence could be impacted.

5. nature.com nature.com/articles/s41746-025-01743-7

Real-time digital intervention on oral pre-exposure ... During follow-ups at 3 and 6 months, the intervention group demonstrated significantly higher PrEP adherence (83.3% and 83.1%) than the control ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36044119/

Using Behavioral Economics to Support PrEP Adherence ... Purpose of review: We explored different behavioral economics (BE) mechanisms through which pre-exposure prophylaxis (PrEP) initiation and ...

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-15429-w

Study protocol for an efficacy trial of the “PrEP for Health ... A multicomponent behavioral intervention to increase PrEP uptake, adherence, and persistence among HIV-negative PWID attending SSPs in two areas of the US ...