Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

Completed

• Conditions: HIV Infections; RNA Virus Infections; Virus Disease; Syphilis; Neisseria Gonorrheae Infection; Chlamydia Trachomatis Infection; Blood-Borne Infections; Infections; Sexually Transmitted Diseases; Communicable Disease
• Interventions: Drug: PrEP; Device: STI testing; Behavioral: Assisted partner notification; Diagnostic Test: Acute HIV testing

• Registration Number: NCT05307991
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-01
• Status Verified: 2023-04
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Index PrEP participants	PrEP	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.
Index PrEP participants	STI testing	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.
Index PrEP participants	Assisted partner notification	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.
Index PrEP participants	Acute HIV testing	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.
Partner participants	STI testing	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.
Non-PrEP participants	STI testing	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.
Partner participants	PrEP	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.
Partner participants	Assisted partner notification	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.
Partner participants	Acute HIV testing	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.

Primary Outcome Measures

Name	Time	Method
Number of participants retained on PrEP	Approximately 6 months after enrollment	Examine the number of participants who initiate PrEP at enrollment who are retained on PrEP through study completion (6 months)
Proportion of participants retained on PrEP	Approximately 6 months after enrollment	Examine the proportion of participants who initiate PrEP at enrollment who are retained on PrEP through study completion (6 months)
Number of provider participants describing feasibility of aPN and STI testing (qualitative)	Approximately 6 months after the start of enrollment	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.
Number of provider participants describing feasibility of aPN and STI testing (quantitative)	Approximately 6 months after the start of enrollment	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.
Number of provider participants describing acceptability of aPN and STI testing (quantitative)	Approximately 6 months after the start of enrollment	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.
Number of patient participants describing acceptability of aPN and STI testing (qualitative)	Approximately 6 months after enrollment	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.
Number of provider participants describing acceptability of aPN and STI testing (qualitative)	Approximately 6 months after the start of enrollment	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.
Number of patient participants describing acceptability of aPN and STI testing (quantitative)	Approximately 6 months after enrollment	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.
Number of patient participants describing feasibility of aPN and STI testing (qualitative)	Approximately 6 months after enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of PrEP eligible STI clinic patients referred for PrEP	Approximately 1 year	The proportion of PrEP eligible STI clinic patients who are referred for PrEP services
Number of PrEP eligible STI clinic patients declining PrEP	Approximately 1 year	Reasons for declining PrEP will be reported qualitatively in order to inform future studies.
Number of PrEP-eligible patients starting PrEP within 7-days of STI screening	Approximately 1 year	The number of PrEP-eligible patients starting PrEP within 7-days of presenting for initial STI screening
Proportion of PrEP-eligible patients starting PrEP within 7-days of STI screening	Approximately 1 year	The proportion of PrEP-eligible patients starting PrEP within 7-days of presenting for initial STI screening
Proportion of STI clinic patients eligible for PrEP	Approximately 1 year	The proportion of STI clinic patients who would meet Malawi PrEP eligibility
Number of PrEP eligible STI clinic patients referred for PrEP	Approximately 1 year	The number of PrEP eligible STI clinic patients who are referred for PrEP services
Number of STI clinic patients eligible for PrEP	Approximately 1 year	The number of STI clinic patients who would meet Malawi PrEP eligibility according to pre-defined criteria
Proportion of all participants retained on PrEP	Up to approximately 6 months	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.
Proportion of enrolled PrEP users naming at least one recent sex partner	Up to approximately 6 months	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
Number of named partners screened for PrEP eligibility	Approximately 1 year	The number of named partners who return for PrEP screening using either passive notification or those who return only after tracing
Proportion of named partners screened for PrEP eligibility	Approximately 1 year	The proportion of named partners who return for PrEP screening using either passive notification or those who return only after tracing
Number of named partners screened for PrEP eligibility who are ineligible for PrEP	Approximately 1 year	Among partners presenting for screening, the number of named partners who are ineligible for PrEP.
Proportion of named partners screened for PrEP eligibility who are ineligible for PrEP	Approximately 1 year	Among partners presenting for screening, the proportion of named partners who are ineligible for PrEP.
Number of PrEP-eligible named partners who initiate PrEP	Approximately 1 year	Among PrEP-eligible partners who present to the clinic, the number who agree to initiate PrEP
Proportion of PrEP-eligible named partners who initiate PrEP	Approximately 1 year	Among PrEP-eligible partners who present to the clinic, the proportion who agree to initiate PrEP
Number of PrEP-eligible named partners who decline PrEP	Approximately 1 year	Reasons for declining PrEP will be reported qualitatively in order to inform future studies.
Proportion of consenting eligible patient participants who receive STI testing	Up to approximately 6 months	The proportion of all participants who receive STI testing at baseline, 0, 3, and 6 months
Proportion of participants who receive appropriate STI treatment within 7 days of testing	Up to approximately 6 months	The proportion of all patient participants who receive indicated treatment, based on results of etiologic STI testing, within 7 days of having been tested
Proportion of participants with symptomatic STI	Up to approximately 6 months	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
Proportion of participants with asymptomatic STI	Up to approximately 6 months	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

Trial Locations

Locations (1)

Bwaila STI clinic; 🇲🇼 Lilongwe, Malawi