HIV InfectionsNCT05307991
Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
An observational study of HIV Infections and Sexually Transmitted Diseases, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases, Blood-Borne Infections
- What is being tested?
- PrEP, STI testing and Assisted partner notification
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 249 participants
- Where
- 1 siteMalawi
- Study dates
- 9 Mar 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- ≥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
Show all 10Show fewer
- 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.
- ≥18 years of age.
- Duties relevant to integration or provision of PrEP and/or aPN at STI clinic
Who cannot join
- Current imprisonment or incarceration in a medical or psychiatric facility
- Provider Participant:
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe
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
- Being tested
- PrEP, STI testing, Assisted partner notification, Acute HIV testing
- Keywords
- Tenofovir, Pre-exposure prophylaxis, emtricitabine, assisted partner notification
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Blood-Borne Infections, Communicable Diseases, Infections, Sexually Transmitted Diseases, Bacterial, Sexually Transmitted Diseases, Viral, RNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPDrug
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.
STI testingDevice
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.
Assisted partner notificationBehavioural
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.
Acute HIV testingDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 6 months after enrollment
Secondary outcomes (20)
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
Measured: Approximately 1 year
Proportion of STI clinic patients eligible for PrEP
The proportion of STI clinic patients who would meet Malawi PrEP eligibility
Measured: Approximately 1 year
Number of PrEP eligible STI clinic patients referred for PrEP
The number of PrEP eligible STI clinic patients who are referred for PrEP services
Measured: Approximately 1 year
Proportion of PrEP eligible STI clinic patients referred for PrEP
The proportion of PrEP eligible STI clinic patients who are referred for PrEP services
Measured: Approximately 1 year
Number of PrEP eligible STI clinic patients declining PrEP
Reasons for declining PrEP will be reported qualitatively in order to inform future studies.
Measured: Approximately 1 year
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
Measured: Approximately 1 year
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
Measured: Approximately 1 year
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.
Measured: Up to approximately 6 months
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
Measured: Up to approximately 6 months
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
Measured: Approximately 1 year
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
Measured: Approximately 1 year
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.
Measured: Approximately 1 year
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.
Measured: Approximately 1 year
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
Measured: Approximately 1 year
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
Measured: Approximately 1 year
Number of PrEP-eligible named partners who decline PrEP
Reasons for declining PrEP will be reported qualitatively in order to inform future studies.
Measured: Approximately 1 year
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
Measured: Up to approximately 6 months
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
Measured: Up to approximately 6 months
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
Measured: Up to approximately 6 months
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
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start9 Mar 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Rutstein, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307991
- Sponsor's protocol ID
- 21-2457
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
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.
PubMed 40604850Rutstein 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.
PubMed 40261957Rutstein 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.
PubMed 36469400
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe
- ClinicalTrials.gov ID
- NCT05307991
- Acronym / sponsor ID
- 21-2457
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Blood-Borne Infections, Communicable Disease, Infections, Sexually Transmitted Diseases, Bacterial
- Keywords
- Tenofovir, Pre-exposure prophylaxis, emtricitabine, assisted partner notification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Index PrEP participants | – | Drug: PrEP, Device: STI testing, Behavioral: Assisted partner notification, Diagnostic Test: Acute HIV testingThis 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. |
| Non-PrEP participants | – | Device: STI testingThis 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 | – | Drug: PrEP, Device: STI testing, Behavioral: Assisted partner notification, Diagnostic Test: Acute HIV testingThis 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. |
| 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- ≥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
- Age ≥15 years
Key exclusion criteria (3 listed)
- Current imprisonment or incarceration in a medical or psychiatric facility
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEPHIV 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. | Drug | Index PrEP participants, Partner participants |
| STI testingUrine 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. | Device | Index PrEP participants, Non-PrEP participants, Partner participants |
| Assisted partner notificationParticipants 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. | Behavioural | Index PrEP participants, Partner participants |
| Acute HIV testingPersons 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). | Diagnostic test | Index PrEP participants, Partner participants |
Primary outcome
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 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)
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 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 (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 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.
20 secondary outcomes
Number of STI clinic patients eligible for PrEP
Time frame: Approximately 1 year
Proportion of STI clinic patients eligible for PrEP
Time frame: Approximately 1 year
Number of PrEP eligible STI clinic patients referred for PrEP
Time frame: Approximately 1 year
Proportion of PrEP eligible STI clinic patients referred for PrEP
Time frame: Approximately 1 year
Number of PrEP eligible STI clinic patients declining PrEP
Time frame: Approximately 1 year
Number of PrEP-eligible patients starting PrEP within 7-days of STI screening
Time frame: Approximately 1 year
Proportion of PrEP-eligible patients starting PrEP within 7-days of STI screening
Time frame: Approximately 1 year
Proportion of all participants retained on PrEP
Time frame: Up to approximately 6 months
Proportion of enrolled PrEP users naming at least one recent sex partner
Time frame: Up to approximately 6 months
Number of named partners screened for PrEP eligibility
Time frame: Approximately 1 year
Proportion of named partners screened for PrEP eligibility
Time frame: Approximately 1 year
Number of named partners screened for PrEP eligibility who are ineligible for PrEP
Time frame: Approximately 1 year
Proportion of named partners screened for PrEP eligibility who are ineligible for PrEP
Time frame: Approximately 1 year
Number of PrEP-eligible named partners who initiate PrEP
Time frame: Approximately 1 year
Proportion of PrEP-eligible named partners who initiate PrEP
Time frame: Approximately 1 year
Number of PrEP-eligible named partners who decline PrEP
Time frame: Approximately 1 year
Proportion of consenting eligible patient participants who receive STI testing
Time frame: Up to approximately 6 months
Proportion of participants who receive appropriate STI treatment within 7 days of testing
Time frame: Up to approximately 6 months
Proportion of participants with symptomatic STI
Time frame: Up to approximately 6 months
Proportion of participants with asymptomatic STI
Time frame: Up to approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 40604850Munthali 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.
- Derived from this study: PubMed 40261957Rutstein 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.
- Derived from this study: PubMed 36469400Rutstein 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.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Rutstein, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Sexually Transmitted Diseases, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants retained on PrEP (time frame: Approximately 6 months after enrollment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307991, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.