A Simple Intervention to Increase Persistence on PrEP in MSM to Improve Decision Making

NCT06476847 | Active Not Recruiting

• 2 other identifiers: H-451131K01MH119923-01A1
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

HIV Infections

Keywords

Pre-exposure prophylaxis (PrEP); Persistence; Vulnerable populations; Men having sex with men (MSM); South Africa

Outcome Measures

Primary Outcomes (3)

• Target population recruitment (feasibility)

  The percent of participants enrolled from those that meet eligibility criteria and are offered will be assessed from screening log.

  18 months

• Fidelity to intervention (feasibility)

  Percent of intervention interactions that are delivered in the first 3 months (Max interactions in 3 months = 2 visit reminders and 24 text messages (2 per week) = 26 total interactions).

  18 months

• Acceptability by intervention participants

  The percent of participants that accept to participate in the intervention (set reminders/receive text messages) after being randomized to the intervention arm.

  18 months

Secondary Outcomes (1)

• PrEP persistence at 3 months, 6 months, and 12 months

  4 months, 7 months, 13 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: PrEP persistence

Control group

NO INTERVENTION

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

Interventions

PrEP persistence BEHAVIORAL

A light touch, once off, low cost. lay counsellor led intervention, designed to focus decision making around HIV prevention addressing present bias, salience and over optimism. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Not currently on pre exposure prophylaxis (PrEP); no PrEP within the last 12 months
• Initiating PrEP on the date of enrolment
• Access to a mobile phone
• Willing and able to provide written informed consent in English

You may not qualify if:

• PrEP status unknown
• Previous PrEP experience within the last year (12 months from enrolment)

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Boston Univeristy School ofPublic Health, Global Health

Boston, Massachusetts, 02118, United States

Location

The Aurum POP INN Clinic

Pretoria, Gauteng, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lawrence C Long, PhD MCom

  Boston University School of Public Health,Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: January 23, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ZA (1)