Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

NCT05307991 | Completed

• 1 other identifier: 21-2457
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (20)

• Number of STI clinic patients eligible for PrEP

  Approximately 1 year

• Proportion of STI clinic patients eligible for PrEP

  Approximately 1 year

• Number of PrEP eligible STI clinic patients referred for PrEP

  Approximately 1 year

• Proportion of PrEP eligible STI clinic patients referred for PrEP

  Approximately 1 year

• Number of PrEP eligible STI clinic patients declining PrEP

  Approximately 1 year

Study Arms (4)

Index PrEP participants

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.

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

Non-PrEP participants

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.

Device: STI testing

Partner participants

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.

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

Providers

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.

Interventions

PrEP DRUG

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.

Index PrEP participants; Partner participants

STI testing DEVICE

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.

Index PrEP participants; Non-PrEP participants; Partner participants

Assisted partner notification BEHAVIORAL

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.

Index PrEP participants; Partner participants

Acute HIV testing DIAGNOSTIC_TEST

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).

Index PrEP participants; Partner participants

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

You may not qualify if:

• Current imprisonment or incarceration in a medical or psychiatric facility
• Provider Participant:
• ≥18 years of age.
• Duties relevant to integration or provision of PrEP and/or aPN at STI clinic
• \- Unable or unwilling to provide informed consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Bwaila STI clinic

Lilongwe, Malawi

Location

Related Publications (3)

• Munthali T, Masano A, Chen JS, Kumwenda W, Pedersen C, Chinthenga K, Jere E, Mathiya E, Ndalama B, Nyirenda N, Bonongwe N, Chagomerana MB, Hosseinipour MC, Hoffman IF, Matoga M, Rutstein SE. Assisted partner notification as a strategy to enhance Pre-Exposure Prophylaxis (PrEP) screening and uptake - results from a prospective cohort study in Lilongwe, Malawi. BMC Health Serv Res. 2025 Jul 2;25(1):890. doi: 10.1186/s12913-025-13038-4.

  PMID: 40604850 DERIVED

• Rutstein SE, Chen JS, Jere E, Limarzi-Klyn L, Mphande Z, Mathiya E, Nyirenda N, Banda G, Mulholland GE, Hosseinipour MC, Hoffman IF, Matoga M. High Incidence of Curable Sexually Transmitted Infections Among Persons Accessing Oral Preexposure Prophylaxis at an Integrated Sexually Transmitted Infection/Preexposure Prophylaxis Clinic in Lilongwe, Malawi. Sex Transm Dis. 2025 Sep 1;52(9):577-584. doi: 10.1097/OLQ.0000000000002170. Epub 2025 Apr 22.

  PMID: 40261957 DERIVED

• Rutstein SE, Matoga M, Chen JS, Mathiya E, Ndalama B, Nyirenda N, Bonongwe N, Chithambo S, Chagomerana M, Tegha G, Hosseinipour MC, Herce ME, Jere E, Krysiak RG, Hoffman IF. Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2022 Dec 5;11(12):e37395. doi: 10.2196/37395.

  PMID: 36469400 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases, Viral; RNA Virus Infections; Virus Diseases; Syphilis; Gonorrhea

Condition Hierarchy (Ancestors)

Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Neisseriaceae Infections

Study Officials

• Sarah Rutstein, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: March 9, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning 9 months following publication and continuing for 36 months
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data sharing agreement with UNC.

Locations

MA (1)