Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe
Overview
- Phase
- N/A
- Intervention
- PrEP
- Conditions
- HIV Infections
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 249
- Locations
- 1
- Primary Endpoint
- Number of participants retained on PrEP
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: PrEP
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.
Intervention: STI testing
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.
Intervention: Assisted partner notification
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.
Intervention: 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.
Intervention: 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.
Intervention: PrEP
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.
Intervention: 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.
Intervention: Assisted partner notification
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.
Intervention: Acute HIV testing
Outcomes
Primary Outcomes
Number of participants retained on PrEP
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)
- Number of PrEP-eligible patients starting PrEP within 7-days of STI screening(Approximately 1 year)
- Proportion of PrEP-eligible patients starting PrEP within 7-days of STI screening(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)
- Number of STI clinic patients eligible for PrEP(Approximately 1 year)
- Proportion of all participants retained on PrEP(Up to approximately 6 months)
- Proportion of enrolled PrEP users naming at least one recent sex partner(Up to approximately 6 months)
- Number of named partners screened for PrEP eligibility(Approximately 1 year)
- Proportion of named partners screened for PrEP eligibility(Approximately 1 year)
- Number of named partners screened for PrEP eligibility who are ineligible for PrEP(Approximately 1 year)
- Proportion of named partners screened for PrEP eligibility who are ineligible for PrEP(Approximately 1 year)
- Number of PrEP-eligible named partners who initiate PrEP(Approximately 1 year)
- Proportion of PrEP-eligible named partners who initiate PrEP(Approximately 1 year)
- Number of PrEP-eligible named partners who decline PrEP(Approximately 1 year)
- Proportion of consenting eligible patient participants who receive STI testing(Up to approximately 6 months)
- Proportion of participants who receive appropriate STI treatment within 7 days of testing(Up to approximately 6 months)
- Proportion of participants with symptomatic STI(Up to approximately 6 months)
- Proportion of participants with asymptomatic STI(Up to approximately 6 months)