Clinical trial NCT05307991: Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
Official title: Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Keywords: Tenofovir
Pre-exposure prophylaxis
emtricitabine
assisted partner notification
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 249
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient participants are PrEP-eligible persons who are seeking care in an STI clinic in Lilongwe, Malawi, including sexual partners who are referred by index participants and initiated on PrEP.

Provider participants include persons who are involved in aspects of patient care that includes: screening for, prescribing, or managing PrEP; eliciting or tracing sexual partners; counseling STI clinic patients on HIV risk and risk reduction. Examples include: clinicians, nurses, HIV testing/aPN counselors, registration staff, community tracers, and clinic management who provide clinical or aPN services.

Brief 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.


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

Primary outcomes:
measure: Proportion of participants retained on PrEP
timeFrame: Approximately 6 months after enrollment
measure: Number of participants retained on PrEP
timeFrame: Approximately 6 months after enrollment
measure: Number of provider participants describing feasibility of aPN and STI testing (qualitative)
timeFrame: Approximately 6 months after the start of enrollment
measure: Number of provider participants describing feasibility of aPN and STI testing (quantitative)
timeFrame: Approximately 6 months after the start of enrollment
measure: Number of provider participants describing acceptability of aPN and STI testing (quantitative)
timeFrame: Approximately 6 months after the start of enrollment
measure: Number of provider participants describing acceptability of aPN and STI testing (qualitative)
timeFrame: Approximately 6 months after the start of enrollment
measure: Number of patient participants describing acceptability of aPN and STI testing (qualitative)
timeFrame: Approximately 6 months after enrollment
measure: Number of patient participants describing acceptability of aPN and STI testing (quantitative)
timeFrame: Approximately 6 months after enrollment
measure: Number of patient participants describing feasibility of aPN and STI testing (qualitative)
timeFrame: Approximately 6 months after enrollment
Secondary outcomes:
measure: Number of STI clinic patients eligible for PrEP
timeFrame: Approximately 1 year
measure: Proportion of STI clinic patients eligible for PrEP
timeFrame: Approximately 1 year
measure: Number of PrEP eligible STI clinic patients referred for PrEP
timeFrame: Approximately 1 year
measure: Proportion of PrEP eligible STI clinic patients referred for PrEP
timeFrame: Approximately 1 year
measure: Number of PrEP eligible STI clinic patients declining PrEP
timeFrame: Approximately 1 year
measure: Number of PrEP-eligible patients starting PrEP within 7-days of STI screening
timeFrame: Approximately 1 year
measure: Proportion of PrEP-eligible patients starting PrEP within 7-days of STI screening
timeFrame: Approximately 1 year
measure: Proportion of all participants retained on PrEP
timeFrame: Up to approximately 6 months
measure: Proportion of enrolled PrEP users naming at least one recent sex partner
timeFrame: Up to approximately 6 months
measure: Number of named partners screened for PrEP eligibility
timeFrame: Approximately 1 year
measure: Proportion of named partners screened for PrEP eligibility
timeFrame: Approximately 1 year
measure: Number of named partners screened for PrEP eligibility who are ineligible for PrEP
timeFrame: Approximately 1 year
measure: Proportion of named partners screened for PrEP eligibility who are ineligible for PrEP
timeFrame: Approximately 1 year
measure: Number of PrEP-eligible named partners who initiate PrEP
timeFrame: Approximately 1 year
measure: Proportion of PrEP-eligible named partners who initiate PrEP
timeFrame: Approximately 1 year
measure: Number of PrEP-eligible named partners who decline PrEP
timeFrame: Approximately 1 year
measure: Proportion of consenting eligible patient participants who receive STI testing
timeFrame: Up to approximately 6 months
measure: Proportion of participants who receive appropriate STI treatment within 7 days of testing
timeFrame: Up to approximately 6 months
measure: Proportion of participants with symptomatic STI
timeFrame: Up to approximately 6 months
measure: Proportion of participants with asymptomatic STI
timeFrame: Up to approximately 6 months
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Bwaila STI clinic
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sarah Rutstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: