Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307991
• Other study ID #: 21-2457
• Status: Completed
• Start date: March 9, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: April 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Malawi	Bwaila STI clinic	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants retained on PrEP	Examine the proportion of participants who initiate PrEP at enrollment who are retained on PrEP through study completion (6 months)	Approximately 6 months after enrollment
Primary	Number of participants retained on PrEP	Examine the number of participants who initiate PrEP at enrollment who are retained on PrEP through study completion (6 months)	Approximately 6 months after enrollment
Primary	Number of provider participants describing feasibility of aPN and STI testing (qualitative)	To gain deeper insights about the feasibility of enhanced PrEP delivery, PrEP providers from the study site will be asked to participate in in-depth interviews. Participating providers are involved in different aspects of PrEP provision, aPN, and STI testing and include study staff members. Feasibility is defined as a positive rating about the intervention's potential performance in real-life conditions at the clinic and community levels.	Approximately 6 months after the start of enrollment
Primary	Number of provider participants describing feasibility of aPN and STI testing (quantitative)	To gain deeper insights about the feasibility of enhanced PrEP delivery, PrEP providers from the study site will be asked to complete survey using modified validated measures assessing feasibility on a 5-point Likert scale. Participating providers are involved in different aspects of PrEP provision, aPN, and STI testing and include study staff members.	Approximately 6 months after the start of enrollment
Primary	Number of provider participants describing acceptability of aPN and STI testing (quantitative)	To gain deeper insights about the acceptability of enhanced PrEP delivery, PrEP providers from the study site will be asked to complete survey using modified validated measures assessing feasibility on a 5-point Likert scale. Participating providers are involved in different aspects of PrEP provision, aPN, and STI testing and include study staff members.	Approximately 6 months after the start of enrollment
Primary	Number of provider participants describing acceptability of aPN and STI testing (qualitative)	To gain deeper insights about the acceptability of enhanced PrEP delivery, PrEP providers from the study site will be asked to participate in in-depth interviews. Participating providers are involved in different aspects of PrEP provision, aPN, and STI testing and include study staff members. Acceptability is defined as a positive rating about the intervention's potential performance in real-life conditions at the clinic and community levels.	Approximately 6 months after the start of enrollment
Primary	Number of patient participants describing acceptability of aPN and STI testing (qualitative)	To gain deeper insights about the acceptability of enhanced PrEP delivery from the patient perspective, as subset of enrolled patients (including persons who initiate PrEP [index], referred partners who initiate PrEP, and persons who decline PrEP) will be asked to participate in in-depth interviews. Acceptability is defined as a positive rating about the intervention's potential performance in real-life conditions at the clinic and community levels.	Approximately 6 months after enrollment
Primary	Number of patient participants describing acceptability of aPN and STI testing (quantitative)	To gain deeper insights about the acceptability of enhanced PrEP delivery from the patient perspective, participants will be asked a series of questions using modified validated measures assessing acceptability on a 4-point Liker scale. Acceptability is defined as a positive rating about the intervention's appeal.	Approximately 6 months after enrollment
Primary	Number of patient participants describing feasibility of aPN and STI testing (qualitative)	To gain deeper insights about the feasibility of enhanced PrEP delivery from the patient perspective, as subset of enrolled patients (including persons who initiate PrEP [index], referred partners who initiate PrEP, and persons who decline PrEP) will be asked to participate in in-depth interviews. Acceptability is defined as a positive rating about the intervention's potential performance in real-life conditions at the clinic and community levels.	Approximately 6 months after enrollment
Secondary	Number of STI clinic patients eligible for PrEP	The number of STI clinic patients who would meet Malawi PrEP eligibility according to pre-defined criteria	Approximately 1 year
Secondary	Proportion of STI clinic patients eligible for PrEP	The proportion of STI clinic patients who would meet Malawi PrEP eligibility	Approximately 1 year
Secondary	Number of PrEP eligible STI clinic patients referred for PrEP	The number of PrEP eligible STI clinic patients who are referred for PrEP services	Approximately 1 year
Secondary	Proportion of PrEP eligible STI clinic patients referred for PrEP	The proportion of PrEP eligible STI clinic patients who are referred for PrEP services	Approximately 1 year
Secondary	Number of PrEP eligible STI clinic patients declining PrEP	Reasons for declining PrEP will be reported qualitatively in order to inform future studies.	Approximately 1 year
Secondary	Number of PrEP-eligible patients starting PrEP within 7-days of STI screening	The number of PrEP-eligible patients starting PrEP within 7-days of presenting for initial STI screening	Approximately 1 year
Secondary	Proportion of PrEP-eligible patients starting PrEP within 7-days of STI screening	The proportion of PrEP-eligible patients starting PrEP within 7-days of presenting for initial STI screening	Approximately 1 year
Secondary	Proportion of all participants retained on PrEP	The proportion of participants (including persons who initiate PrEP [index], referred partners who initiate PrEP, and persons who initially decline PrEP but start during study follow-up) who are retained on PrEP at 1, 3, and 6 months of follow-up.	Up to approximately 6 months
Secondary	Proportion of enrolled PrEP users naming at least one recent sex partner	The proportion of PrEP users who name at least one recent sex partner, defined as having had sex with them in the prior 6 months, for assisted partner notification	Up to approximately 6 months
Secondary	Number of named partners screened for PrEP eligibility	The number of named partners who return for PrEP screening using either passive notification or those who return only after tracing	Approximately 1 year
Secondary	Proportion of named partners screened for PrEP eligibility	The proportion of named partners who return for PrEP screening using either passive notification or those who return only after tracing	Approximately 1 year
Secondary	Number of named partners screened for PrEP eligibility who are ineligible for PrEP	Among partners presenting for screening, the number of named partners who are ineligible for PrEP.	Approximately 1 year
Secondary	Proportion of named partners screened for PrEP eligibility who are ineligible for PrEP	Among partners presenting for screening, the proportion of named partners who are ineligible for PrEP.	Approximately 1 year
Secondary	Number of PrEP-eligible named partners who initiate PrEP	Among PrEP-eligible partners who present to the clinic, the number who agree to initiate PrEP	Approximately 1 year
Secondary	Proportion of PrEP-eligible named partners who initiate PrEP	Among PrEP-eligible partners who present to the clinic, the proportion who agree to initiate PrEP	Approximately 1 year
Secondary	Number of PrEP-eligible named partners who decline PrEP	Reasons for declining PrEP will be reported qualitatively in order to inform future studies.	Approximately 1 year
Secondary	Proportion of consenting eligible patient participants who receive STI testing	The proportion of all participants who receive STI testing at baseline, 0, 3, and 6 months	Up to approximately 6 months
Secondary	Proportion of participants who receive appropriate STI treatment within 7 days of testing	The proportion of all patient participants who receive indicated treatment, based on results of etiologic STI testing, within 7 days of having been tested	Up to approximately 6 months
Secondary	Proportion of participants with symptomatic STI	The proportion of all patient participants (including persons who initiate PrEP [index], referred partners who initiate PrEP, and persons who initially decline PrEP) who have a symptomatic STI at enrollment, 1, 3, or 6 months	Up to approximately 6 months
Secondary	Proportion of participants with asymptomatic STI	The proportion of all patient participants (including persons who initiate PrEP [index], referred partners who initiate PrEP, and persons who initially decline PrEP) who have an asymptomatic STI at enrollment, 1, 3, or 6 months	Up to approximately 6 months