Clinical trial

Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe

Name

21-2457

Description

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.

Trial arms

Trial start

2022-03-09

Estimated PCD

2023-08-01

Trial end

2023-08-01

Status

Completed

Treatment

PrEP

HIV pre-exposure prophylaxis (or PrEP) will include the Malawi-approved PrEP regimen at time of study enrollment. At time of submission, the only Malawi-approved regimen includes Tenofovir/emtricitabine (TDF/FTC) containing 300 mg of TDF and 200 mg of FTC. If additional PrEP regimens become available in Malawi during the study recruitment or follow-up, participants will be able to choose from any regimen that they are eligible to receive per Malawi PrEP guidelines.

Arms:

Index PrEP participants, Partner participants

STI testing

Urine specimens will be tested for Chlamydia trachomatis (Ct) and Neisseria gonorrhoeae (GC) using GeneXpert® (Cepheid, Sunnyvale, CA) Xpert® CT/GC platform and cartridge and syphilis RPR titer (BD Macro-VUE™, Becton, Dickinson and Company, Franklin Lakes, NJ \[FDA approved\]) with confirmatory Treponema pallidum particle agglutination (TP-PA) (Serodia Fujirebio Inc, Malvern, PA \[CE mark\]) if RPR is positive.

Arms:

Index PrEP participants, Non-PrEP participants, Partner participants

Assisted partner notification

Participants will be asked to provide the name and locator information for all sexual partners in the preceding 6 months. Participants will be asked to refer sexual partners to the clinic and will be provided with cards to distribute to partners. Each card will request that the recipient report to the STI clinic with the card and will contain a linking number that links them back to the index participant. Sexual Partner Tracing: In accordance with the contract referral approach, if the named partners do not present to an STI clinic within 7-14 days, community outreach workers will contact the partners and counsel them to visit the clinic. Contact may be made through telephone, text message, or in person, as needed and will not disclose the name or identify of the index patient.

Arms:

Index PrEP participants, Partner participants

Acute HIV testing

Persons initiating or re-initiating PrEP will also be screened for acute HIV infection (AHI) using Abbott RealTime HIV-1 Assay (Abbott Laboratories, Chicago, IL) or Xpert® HIV-1 Viral Load (GeneXpert, Cepheid, Sunnyvale, CA).

Arms:

Index PrEP participants, Partner participants

Size

249

Primary endpoint

Proportion of participants retained on PrEP

Approximately 6 months after enrollment

Number of participants retained on PrEP

Approximately 6 months after enrollment

Number of provider participants describing feasibility of aPN and STI testing (qualitative)

Approximately 6 months after the start of enrollment

Number of provider participants describing feasibility of aPN and STI testing (quantitative)

Approximately 6 months after the start of enrollment

Number of provider participants describing acceptability of aPN and STI testing (quantitative)

Approximately 6 months after the start of enrollment

Number of provider participants describing acceptability of aPN and STI testing (qualitative)

Approximately 6 months after the start of enrollment

Number of patient participants describing acceptability of aPN and STI testing (qualitative)

Approximately 6 months after enrollment

Number of patient participants describing acceptability of aPN and STI testing (quantitative)

Approximately 6 months after enrollment

Number of patient participants describing feasibility of aPN and STI testing (qualitative)

Approximately 6 months after enrollment

Eligibility 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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 249, 'type': 'ACTUAL'}}

Updated at

2023-10-05

1 organization

1 product

12 indications

Organization

University of North Carolina, Chapel Hill

Product

PrEP

Indication

HIV Infections

Indication