Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

University of North Carolina (UNC)

Status: Completed

Conditions: Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Neisseria Gonorrheae Infection; Infections; HIV Infections; Syphilis; RNA Virus Infections; Chlamydia Trachomatis Infection; Communicable Disease; Sexually Transmitted Diseases, Viral; Blood-Borne Infections; Virus Disease

Treatments: Behavioral: Assisted partner notification; Diagnostic Test: Acute HIV testing; Drug: PrEP; Device: STI testing

Study type: Observational

Funder types: Other

Identifiers

NCT05307991

21-2457

Details and patient eligibility

About

This is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating HIV pre-exposure prophylaxis (PrEP) into a sexually transmitted infection (STI) clinic alongside assisted partner notification and etiologic STI testing in Lilongwe, Malawi.

Enrollment: 249 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patient Participant

Inclusion Criteria:

• ≥15 years of age.

• Eligible for PrEP according to Malawi PrEP guidelines (see below)

• Presenting for care at STI clinic (primary presentation or referral from partner based on STI or HIV exposure)

• Able to consent for study participation and willing to provide locator information for follow-up tracing

  *Malawi PrEP eligibility criteria:

• Age ≥15 years

• HIV seronegative iii. At substantial risk for HIV, with prioritization of persons who:

• Buy or sell sex; Key population (female sex worker, men who have sex with other men, transgendered persons; Vulnerable population included adolescent girls and young women aged 15-24; STI clients; Serodiscordant couples including HIV-negative women who are pregnant or breast feeding or HIV-negative men or women for whom their HIV-infected partner is: not on ART, on ART <6 months, has an unsuppressed or high viral load, or is non-adherent to ART, iv. Have ruled out acute HIV infection, or defer PrEP initiation for anyone with signs or symptoms consistent with acute HIV infection, v. Willingness to attend scheduled PrEP visits, vi. No contraindication to use of TDF and 3TC, vii. Bodyweight ≥30 kg, viii. Estimated glomerular filtration rate (eGFR) ≥60mL/min, ix. No known renal diseases, x. No diabetes mellitus.

Exclusion Criteria:

• Current imprisonment or incarceration in a medical or psychiatric facility

Provider Participant:

Inclusion Criteria:

• ≥18 years of age.
• Duties relevant to integration or provision of PrEP and/or aPN at STI clinic

Exclusion Criteria:

• Unable or unwilling to provide informed consent

Trial design

249 participants in 4 patient groups

Index PrEP participants

Description:

This group includes persons 15 years and older who are started on PrEP at the STI clinic. Participants in this group will be followed for 6 months, with follow-up visits at 1, 3, and 6 months, and will be asked to refer sexual partners from the preceding 6 months as well as any new sexual partners throughout the study period. They will also receive testing for Neisseria gonorrhea, Chlamydia trachomatis, and syphilis (depending on prior results) at baseline, 3, and 6 months. A sub-group of participants will also complete in-depth interviews to contextualize observed behaviors and outcomes.

Treatment:

Device: STI testing

Behavioral: Assisted partner notification

Drug: PrEP

Diagnostic Test: Acute HIV testing

Non-PrEP participants

Description:

This group includes persons who are eligible to receive PrEP but who decline initiation at their index visit to the STI clinic. These participants will be followed for 6 months, with follow-up visits at 3 and 6 months, and receive testing for Neisseria gonorrhea, Chlamydia trachomatis, and syphilis (depending on prior results) at baseline, 3, and 6 months. However, at any time during the follow-up period these persons can choose to initiate PrEP. This would not change their follow-up frequency nor their assigned group, and they would continue to be followed for 6 months from the date of initial enrollment. A sub-group of participants will also complete in-depth interviews to contextualize observed behaviors and outcomes.

Treatment:

Device: STI testing

Partner participants

Description:

This group is made up of named/referred partners from the Group 1 (Index PrEP participant) who are eligible for and agree to start PrEP. They will receive identical intervention to that of the Group 1, specifically: this group will be followed for 6 months, with follow-up visits at 1, 3, and 6 months, and will be asked to refer sexual partners from the preceding 6 months as well as any new sexual partners throughout the study period. They will also receive testing for Neisseria gonorrhea, Chlamydia trachomatis, and syphilis (depending on prior results) at baseline, 3, and 6 months. A sub-group of participants will also complete in-depth interviews to contextualize observed behaviors and outcomes.

Treatment:

Device: STI testing

Behavioral: Assisted partner notification

Drug: PrEP

Diagnostic Test: Acute HIV testing

Providers

Description:

This group is made up providers involved in the provision of PrEP or other related services including STI management, HIV testing or counseling, or assisted partner notification (aPN). Examples include: clinicians, nurses, HIV testing/aPN counselors, registration staff, community tracers, and clinic management who provide clinical or aPN services. These participants will be asked to complete a survey responding to acceptability, feasibility, and appropriateness of the enhanced PrEP implementation strategy as an integrated strategy within the STI clinic. They will also participate in in-depth interviews. These activities will be completed at baseline and approximately 6 months thereafter.