HIV Infection, Pre-exposure Prophylaxis, Sexually Transmitted Infections, Systems Navigation
Conditions
Keywords
HIV, STI, PrEP, Heterosexual, Lilongwe, Malawi, Systems Navigation
Brief summary
To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis (PrEP) among heterosexual men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.
Interventions
OTHERPrEP eligibility assessment
PrEP eligibility assessment
DIAGNOSTIC_TESTRapid HIV antibody testing prior to provision and/or refill of PrEP
Rapid HIV antibody testing prior to provision and/or refill of PrEP
OTHERPrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
BEHAVIORALEvaluation of barriers and facilitators to ongoing PrEP use
Evaluation of barriers and facilitators to ongoing PrEP use
OTHERPoint of contact STI testing to inform counseling regarding ongoing PrEP care engagement
Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement
OTHERTracing for any missed PrEP visits
Tracing for any missed PrEP visits
OTHEROffering a PrEP restart kit for men who choose to discontinue PrEP during the follow-up period
Offering a PrEP restart kit for men who choose to discontinue PrEP during the follow-up period
Sponsors
Division of AIDS, US National Institute of Allergy and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult and adolescent men who meet all of the following criteria are eligible for inclusion in this study as a participant initiating PrEP: * Age ≥18 years, or age 15-17 (with assent and parent/guardian consent) * Able to provide informed consent * No plans to move outside study area for at least 26 weeks after study enrollment * Willing to provide contact/locator information, including phone number, to facilitate tracing * Willing to participate in study activities, including specimen collection * Willing to participate in study activities, including systems navigation, counseling, and point of contact STI testing * Sought STI clinic services within 7 days of enrollment * Initiated on PrEP at STI clinic within 7 days of enrollment * Reports at least one female sex partner in the 6 months prior to enrollment * Self-identifies as heterosexual 2. Individuals who meet all of the following criteria are eligible for inclusion in this study as other key stakeholders: * Age ≥18 years at the enrollment visit * Able to provide informed consent * Involved in provision of clinical service navigation, systems navigation, STI or HIV care or prevention (including clinic management or oversight), or development of HIV prevention policy or programs at local or national level
Exclusion criteria
1. Adult and adolescent men who meet any of the following criteria are ineligible for inclusion in this study as a participant initiating PrEP: * Appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators * Any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the conduct of the study * Current participation in any HIV prevention study or other study considered to interfere the interpretation of study outcomes. 2. Individuals who meet any of the following criteria are ineligible for inclusion in this study as other key stakeholder: * Appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators * Any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the study activities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi | 26 weeks | Consistent with this primary study objective, the following endpoint will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing proportions in intervention and control arm participants. LAI: Receive on-time injections (+/- 7-day window for the first injection and 14-day window thereafter) |
| To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics | 7 days | Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Proportion of intervention arm participants engaged by systems navigator within 7-days of enrollment visit (defined as any contact, i.e. text exchange, in-person communication) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the feasibility of a future randomized controlled trial | 52 weeks | Consistent with this secondary study objective, the following endpoint will be assessed, considering all enrolled HIV seronegative participants: Calendar time to enroll 200 participants |
Countries
Malawi
Outcome results
None listed