NCT05307991

Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 249 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	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.
DEVICE	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.
BEHAVIORAL	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.
DIAGNOSTIC_TEST	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).

Timeline

• Start date: 2022-03-09
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2022-04-01
• Last updated: 2023-10-05

Locations

1 site across 1 country: Malawi