140 Participants Needed

Increasing PrEP Persistence for HIV Prevention

Recruiting at 3 trial locations
LC
Overseen ByLawrence C Long, PhD MCom
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Boston University
Must be taking: PrEP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM).This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial.Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months.

Research Team

LC

Lawrence C Long, PhD MCom

Principal Investigator

Boston University School of Public Health,Global Health

Eligibility Criteria

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.
See 1 more

Exclusion Criteria

PrEP status unknown
I have used PrEP in the last year.

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 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 groupActive Control1 Intervention
Usual care for high risk men newly initiating PrEP in South Africa.

Find a Clinic Near You

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+
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