BreastfeedingLINKNCT06506188
Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
A study testing LINK model in people with Breastfeeding and HIV Prevention, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among post-partum women and its implementation into existing clinical care models in Lilongwe… Read more about this study
- Who is it for?
- Ages 15 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, HIV Prevention
- What is being tested?
- LINK model
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteMalawi
- Study dates
- 15 Sep 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female enrolled in PrEP care at a study site
- Breastfeeding documented while on PrEP
- Living without HIV
- Female who has presented for PrEP visit at a participating clinical site at least ~6 months after initiating PrEP
- Aged 15 years (assent with parental/guardian consent for women aged 15-17)
- Living without HIV
Show all 11Show fewer
- Female presenting with infant under 3 for under-five visit to participating clinical site
- Female presenting for child vaccination to participating clinical site
- Aged15 years and older (assent with parental/guardian consent for women aged 15-17)
- Aged 18 years and older
- Involved in relevant activities pertinent to integration or provision of PrEP services such as PrEP providers, peer mothers, HIV diagnostic assistants, or clinic managers, OR policy and implementing partner stakeholders such as officials from the Malawi Ministry of Health, donors in HIV prevention (e.g. PEPFAR, the Global Fund), members of community advocacy groups, the Lilongwe DHO, and other persons involved in infant vaccine and HIV prevention program and policy development and implementation in HIV prevention in Lilongwe
Who cannot join
- None
- PrEP user survey and dried blood spot sub-group Breastfeeding women 15 years and older who are presenting ~6 months after initiating PrEP are eligible participation in study surveys and dried blood spot using fingerstick specimen collection. Women aged 15-17 will be asked to provide assent with parental/guardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.
- Decline informed consent
- Postpartum women - health passport review We review use existing health records (Health passports) of postpartum women presenting to infant immunization appointments with their child. No identifying information will be collected from this group.
- None
- Postpartum women - surveys Postpartum women 15 years and older who are presenting to under-five visits with their child under 3 will be eligible for participation in study surveys. Women aged 15-17 will be asked to provide assent with parental/guardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.
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- Decline informed consent
- Non-patient key stakeholder Non-patient stakeholders relevant to intervention implementation at the clinic and national level, including clinical and policy stakeholders. Examples of clinical stakeholders may include key clinic staff working in PrEP, HIV testing, EPI, and CFL peer support mothers. Policy and implementing partner stakeholders may include officials from the Malawi Ministry of Health, donors in HIV prevention (e.g. PEPFAR, the Global Fund), members of community advocacy groups, the Lilongwe DHO, and other persons involved in infant vaccine and HIV prevention program and policy development and implementation in HIV prevention in Lilongwe.
- Decline informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site, 1 recruiting
- Recruiting
University of North Carolina Project Malawi (UNCPM)
Lilongwe
Friday Saidi, MBBS, MMED, fsaidi@email.unc.edu
About this study
Official title: UNCPM 22402 - Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among post-partum women and its implementation into existing clinical care models in Lilongwe, Malawi. The main question the study seeks to answer is:
Do women at clinics implementing the LINK model have improved Pre-exposure Prophylaxis (PrEP) persistence compared to women at clinics receiving the standard of care?
Researchers will compare the LINK model to standard of care by randomizing twelve sites to either the LINK model or the standard of care. Then researchers will review existing medical record and health surveillance data, and qualitative and quantitative data collected from intervention and control sites.
Read the detailed description
Study Design Overview:
The LINK study is an effectiveness-implementation type I hybrid cluster randomized trial. Prospective data collection and existing medical record and health surveillance data will be used to evaluate the effectiveness and implementation of the LINK model. The LINK model is a clinical intervention aiming to improve PrEP persistence among postpartum women. Outcomes from this trial will be used to assess its potential for implementation outside of the trial setting.
The study will take place in Lilongwe district in Malawi, a priority district for HIV prevention services given high HIV incidence. Twelve sites in Lilongwe will be randomized 1:1 to the LINK model or the standard of care.
The LINK model includes:
- Linking postpartum HIV testing and PrEP services to early infant vaccination
- Screening for HIV risk among those who test negative for HIV at the early infant vaccination visit
- Male partner engagement to support status awareness within couples and PrEP persistence
- Community facility-linkage (CFL) peer mom for ongoing support of breastfeeding moms using PrEP, and follow-up of breastfeeding women who disengage from PrEP care
Components #1-3 are directly integrated into the Expanded Programme on Immunization (EPI) infant vaccination visit and will be carried out by a mix of existing staff and study-hired HIV diagnostic assistants (HDA). HDAs are a lower healthcare worker cadre that Malawi has successfully deployed to expand HIV testing services. Component #4 will take place outside of the infant immunization clinic, integrated into existing PrEP clinics and clinic flow at each site. Component #4 will shift the tasks of engaging women, exploring strategies to facilitate ongoing PrEP care attendance, and tracing persons who disengage from care from the the PrEP prescriber (typically a nurse) to the CFL "PrEP peer" mother. The study anticipates supporting placement of one PrEP-trained HDA and at least one CFL "PrEP peer" at each intervention site. All PrEP services, including clinical evaluation and medication refill or administration, will be provided by Malawi Ministry of Health (MoH) and/or local implementing partners tasked with PrEP delivery.
Data collection methods will include structured observation, medical record review, surveys, and in-depth interviews (IDI) with patients in each of the twelve clinics. The primary outcome, PrEP persistence, will be assessed by PrEP medical record review of patients at intervention and control clinics. Additionally, there will be study-specific data collection tools including surveys, IDI, and dried blood spots (DBS) administered to participants consented and enrolled into the study at intervention and control clinics. Participants will not be followed longitudinally. Study data assistants will administer surveys at each participating site for women receiving services related to infant vaccines and PrEP care. These surveys will collect demographic information, HIV risks, and PrEP utilization (if applicable). Researchers will collect DBS from a subset of women who initiated PrEP to measure oral PrEP adherence.
A subset of women in intervention clinics, including those receiving services at the PrEP and/or EPI clinics, as well as clinical providers, implementing partners, and members of the Malawi Ministry of Health will be asked to participate in an IDI focused on acceptability and feasibility of the intervention. For women, interviews will focus on experiences with each component of the intervention and partner support for HIV testing and PrEP usage during the postpartum period. Non-patient stakeholders' interviews will focus on context and feasibility of implementation, scale, and sustainability of the LINK model.
- Conditions
- Breastfeeding, HIV Prevention
- Being tested
- LINK model
- Keywords
- Breastfeeding, HIV
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINK modelBehavioural
The LINK model includes four elements:
(1) linking postpartum HIV testing and PrEP services to early infant vaccination, (2) screening for HIV risk among those who test negative for HIV at the early infant vaccination visit, (3) male partner engagement to support status awareness within couples and PrEP persistence, and (4) community-facility linkage (CFL) peer mom for ongoing support of breastfeeding women using PrEP and follow-up of breastfeeding women who disengage from PrEP care.
| Study group | Role | What they receive |
|---|---|---|
| LINK model | Experimental | Women at these sites receive the LINK model, which includes integrated EPI/HIV testing, screening for HIV risk, support for male partner engagement, and community-facility linkage (CFL) peer moms for breastfeeding women using PrEP for ongoing support and follow-up for breastfeeding women who disengage from PrEP care. This model is integrated into the SOC and does not replace SOC activities. Receives: Behavioral: LINK model |
| Standard of Care | No intervention | Women at these sites continue to receive the current standard of care (SOC) for postpartum HIV testing, PrEP screening, and PrEP care in Malawi. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP persistence: Proportion of patients on PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
Proportion of breastfeeding patients with health record-reported PrEP use (oral or injectable) who maintain ongoing PrEP usage with no more than a 14-day lapse of expected available pills or timely injections from oral or injectable PrEP approximately 6 months after PrEP initiation, among the total number of breastfeeding patients with health record-reported PrEP use (oral or injectable)
Measured: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
PrEP uptake: Proportion of patients initiating PrEP while breastfeeding among HIV-negative deliveries at the clinic in the past year
Proportion of number of breastfeeding patients with record-reported initiation of PrEP (oral or injectable) in the study period, among HIV-negative deliveries in a clinic in the study period
Measured: Study start to study end (approximately 3.5 years)
Oral PrEP adherence: Proportion of patients on oral PrEP with PrEP metabolite levels consistent with >=4 pills per week at a 6-month oral PrEP visit
Proportion of breastfeeding patients with record-reported use of PrEP (oral) at 6-month visit consistent with PrEP metabolite levels consistent with >=4 pills per week among all breastfeeding patients consented to provide samples with record-reported use of PrEP (oral) at 6-month visit and metabolite levels tested
Measured: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
Secondary outcomes (6)
Oral PrEP persistence: Proportion of patients on oral PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
Proportion of breastfeeding patients with health record-reported oral PrEP use who maintain ongoing PrEP usage with no more than a 14-day lapse of expected available pills from oral PrEP approximately 6 months after PrEP initiation, among the total number of breastfeeding patients with health record-reported oral PrEP use
Measured: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
Injectable PrEP persistence: Proportion of patients on injectable PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
Proportion of breastfeeding patients with health record-reported injectable PrEP use who maintain ongoing PrEP usage with no more than a 14-day lapse of timely injections from injectable PrEP approximately 6 months after PrEP initiation, among the total number of breastfeeding patients with health record-reported injectable PrEP use
Measured: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
PrEP persistence: Proportion of patients on PrEP for 12 months after initiation with no lapse of PrEP coverage exceeding 14 days
Proportion of breastfeeding patients with health record-reported PrEP use (oral or injectable) who maintain ongoing PrEP usage with no more than a 14-day lapse from oral or injectable PrEP at 12 months, among the total number of breastfeeding patients with health record-reported PrEP use (oral or injectable)
Measured: PrEP initiation or initiation of breastfeeding while on PrEP through 12 months
Oral PrEP adherence: Proportion of patients on oral PrEP with PrEP metabolite levels consistent with >=4 pills per week at a 12-month oral PrEP visit
Proportion of breastfeeding patients with record-reported use of PrEP (oral) at 12-month visit with PrEP metabolite levels consistent with >=4 pills per week among all breastfeeding patients consented to provide samples with record-reported use of PrEP (oral) at 12-month visit and metabolite levels tested
Measured: PrEP initiation or initiation of breastfeeding while on PrEP through 12 months
Adoption: Number of referrals from all sources to CFL peer mothers
Number of referrals to CFL peer moms based on CFL peer mom tracking systems across all intervention sites assessed via repeat cross-sectional surveys from study start to study end
Measured: From study start through study end (approximately 3.5 years)
Adoption: Number of referrals from PrEP providers to CFL peer mothers
Number of referrals from PrEP providers to CFL peer mothers based on CFL peer mother tracking systems across all intervention sites assessed via repeat cross-sectional surveys from study start to study end
Measured: From study start through study end (approximately 3.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start15 Sep 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an effectiveness-implementation type I hybrid cluster randomized trial which includes prospective data collection (both quantitative and qualitative) as well as use of existing surveillance data to inform pre-defined effectiveness and implementation outcomes of interest. Randomization and implementation of the LINK model occurs at the clinic level, and individuals are considered exposed or unexposed based on their attendance at intervention or control clinics.
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Sarah E Rutstein, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506188
- Sponsor's protocol ID
- 24-0323
- Other IDs
- 1P01HD112215
- Acronym
- LINK
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2024
- Last updated
- 30 Sep 2026
- 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 University of North Carolina (UNC).
Publications
Rutstein SE, Lucas VA, Hosseinipour MC, Herce ME, Edwards J, Cassidy C, Villiera J, Kamanga F, Chagomerana M, van Oosterhout JJ, Chikuse E, Rambiki E, Thawani A, Malewezi B, Makhupula L, Udedi C, Mbulaje P, Matoga M, Kumwenda W, Mvalo T, Bula A, Nkhalamba L, Mofolo I, Chinula L, Thonyiwa V, Kumwenda O, Chisema MN, Hoffman IF, Miller WC, Go VF, Pence B, Squibb MA, Saidi F. Leveraging infant visit PrEP screening INtegration & tasK shifting to improve post-partum HIV prevention in Malawi (LINK): a cluster-randomized trial evaluation of a postpartum HIV prevention package among breastfeeding women in Malawi. BMC Health Serv Res. 2025 Aug 19;25(1):1107. doi: 10.1186/s12913-025-13133-6.
PubMed 40830473
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNCPM 22402 - Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
- ClinicalTrials.gov ID
- NCT06506188
- Acronym / sponsor ID
- LINK / 24-0323
- Conditions
- Breastfeeding, HIV Prevention
- Keywords
- Breastfeeding, HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Jul 2024 (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.
The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among post-partum women and its implementation into existing clinical care models in Lilongwe, Malawi. The main question the study seeks to answer is:
Do women at clinics implementing the LINK model have improved Pre-exposure Prophylaxis (PrEP) persistence compared to women at clinics receiving the standard of care?
Researchers will compare the LINK model to standard of care by randomizing twelve sites to either the LINK model or the standard of care. Then researchers will review existing medical record and health surveillance data, and qualitative and quantitative data collected from intervention and control sites.
Detailed description
Study Design Overview:
The LINK study is an effectiveness-implementation type I hybrid cluster randomized trial. Prospective data collection and existing medical record and health surveillance data will be used to evaluate the effectiveness and implementation of the LINK model. The LINK model is a clinical intervention aiming to improve PrEP persistence among postpartum women. Outcomes from this trial will be used to assess its potential for implementation outside of the trial setting.
The study will take place in Lilongwe district in Malawi, a priority district for HIV prevention services given high HIV incidence. Twelve sites in Lilongwe will be randomized 1:1 to the LINK model or the standard of care.
The LINK model includes:
- Linking postpartum HIV testing and PrEP services to early infant vaccination
- Screening for HIV risk among those who test negative for HIV at the early infant vaccination visit
- Male partner engagement to support status awareness within couples and PrEP persistence
- Community facility-linkage (CFL) peer mom for ongoing support of breastfeeding moms using PrEP, and follow-up of breastfeeding women who disengage from PrEP care
Components #1-3 are directly integrated into the Expanded Programme on Immunization (EPI) infant vaccination visit and will be carried out by a mix of existing staff and study-hired HIV diagnostic assistants (HDA). HDAs are a lower healthcare worker cadre that Malawi has successfully deployed to expand HIV testing services. Component #4 will take place outside of the infant immunization clinic, integrated into existing PrEP clinics and clinic flow at each site. Component #4 will shift the tasks of engaging women, exploring strategies to facilitate ongoing PrEP care attendance, and tracing persons who disengage from care from the the PrEP prescriber (typically a nurse) to the CFL "PrEP peer" mother. The study anticipates supporting placement of one PrEP-trained HDA and at least one CFL "PrEP peer" at each intervention site. All PrEP services, including clinical evaluation and medication refill or administration, will be provided by Malawi Ministry of Health (MoH) and/or local implementing partners tasked with PrEP delivery.
Data collection methods will include structured observation, medical record review, surveys, and in-depth interviews (IDI) with patients in each of the twelve clinics. The primary outcome, PrEP persistence, will be assessed by PrEP medical record review of patients at intervention and control clinics. Additionally, there will be study-specific data collection tools including surveys, IDI, and dried blood spots (DBS) administered to participants consented and enrolled into the study at intervention and control clinics. Participants will not be followed longitudinally. Study data assistants will administer surveys at each participating site for women receiving services related to infant vaccines and PrEP care. These surveys will collect demographic information, HIV risks, and PrEP utilization (if applicable). Researchers will collect DBS from a subset of women who initiated PrEP to measure oral PrEP adherence.
A subset of women in intervention clinics, including those receiving services at the PrEP and/or EPI clinics, as well as clinical providers, implementing partners, and members of the Malawi Ministry of Health will be asked to participate in an IDI focused on acceptability and feasibility of the intervention. For women, interviews will focus on experiences with each component of the intervention and partner support for HIV testing and PrEP usage during the postpartum period. Non-patient stakeholders' interviews will focus on context and feasibility of implementation, scale, and sustainability of the LINK model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an effectiveness-implementation type I hybrid cluster randomized trial which includes prospective data collection (both quantitative and qualitative) as well as use of existing surveillance data to inform pre-defined effectiveness and implementation outcomes of interest. Randomization and implementation of the LINK model occurs at the clinic level, and individuals are considered exposed or unexposed based on their attendance at intervention or control clinics.
| Arm | Type | Receives |
|---|---|---|
| LINK model | Experimental | Behavioral: LINK modelWomen at these sites receive the LINK model, which includes integrated EPI/HIV testing, screening for HIV risk, support for male partner engagement, and community-facility linkage (CFL) peer moms for breastfeeding women using PrEP for ongoing support and follow-up for breastfeeding women who disengage from PrEP care. This model is integrated into the SOC and does not replace SOC activities. |
| Standard of Care | No intervention | –Women at these sites continue to receive the current standard of care (SOC) for postpartum HIV testing, PrEP screening, and PrEP care in Malawi. |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Female enrolled in PrEP care at a study site
- Breastfeeding documented while on PrEP
- Living without HIV
- Female who has presented for PrEP visit at a participating clinical site at least ~6 months after initiating PrEP
- Aged 15 years (assent with parental/guardian consent for women aged 15-17)
Key exclusion criteria (9 listed)
- None
- PrEP user survey and dried blood spot sub-group Breastfeeding women 15 years and older who are presenting ~6 months after initiating PrEP are eligible participation in study surveys and dried blood spot using fingerstick specimen collection. Women aged 15-17 will be asked to provide assent with parental/guardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.
- Decline informed consent
- Postpartum women - health passport review We review use existing health records (Health passports) of postpartum women presenting to infant immunization appointments with their child. No identifying information will be collected from this group.
- None
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 |
|---|---|---|
| LINK modelThe LINK model includes four elements: (1) linking postpartum HIV testing and PrEP services to early infant vaccination, (2) screening for HIV risk among those who test negative for HIV at the early infant vaccination visit, (3) male partner engagement to support status awareness within couples and PrEP persistence, and (4) community-facility linkage (CFL) peer mom for ongoing support of breastfeeding women using PrEP and follow-up of breastfeeding women who disengage from PrEP care. | Behavioural | LINK model |
Primary outcome
PrEP persistence: Proportion of patients on PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
Time frame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
Proportion of breastfeeding patients with health record-reported PrEP use (oral or injectable) who maintain ongoing PrEP usage with no more than a 14-day lapse of expected available pills or timely injections from oral or injectable PrEP approximately 6 months after PrEP initiation, among the total number of breastfeeding patients with health record-reported PrEP use (oral or injectable)
PrEP uptake: Proportion of patients initiating PrEP while breastfeeding among HIV-negative deliveries at the clinic in the past year
Time frame: Study start to study end (approximately 3.5 years)
Proportion of number of breastfeeding patients with record-reported initiation of PrEP (oral or injectable) in the study period, among HIV-negative deliveries in a clinic in the study period
Oral PrEP adherence: Proportion of patients on oral PrEP with PrEP metabolite levels consistent with >=4 pills per week at a 6-month oral PrEP visit
Time frame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
Proportion of breastfeeding patients with record-reported use of PrEP (oral) at 6-month visit consistent with PrEP metabolite levels consistent with >=4 pills per week among all breastfeeding patients consented to provide samples with record-reported use of PrEP (oral) at 6-month visit and metabolite levels tested
6 secondary outcomes
Oral PrEP persistence: Proportion of patients on oral PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
Time frame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
Injectable PrEP persistence: Proportion of patients on injectable PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
Time frame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
PrEP persistence: Proportion of patients on PrEP for 12 months after initiation with no lapse of PrEP coverage exceeding 14 days
Time frame: PrEP initiation or initiation of breastfeeding while on PrEP through 12 months
Oral PrEP adherence: Proportion of patients on oral PrEP with PrEP metabolite levels consistent with >=4 pills per week at a 12-month oral PrEP visit
Time frame: PrEP initiation or initiation of breastfeeding while on PrEP through 12 months
Adoption: Number of referrals from all sources to CFL peer mothers
Time frame: From study start through study end (approximately 3.5 years)
Adoption: Number of referrals from PrEP providers to CFL peer mothers
Time frame: From study start through study end (approximately 3.5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 40830473Rutstein SE, Lucas VA, Hosseinipour MC, Herce ME, Edwards J, Cassidy C, Villiera J, Kamanga F, Chagomerana M, van Oosterhout JJ, Chikuse E, Rambiki E, Thawani A, Malewezi B, Makhupula L, Udedi C, Mbulaje P, Matoga M, Kumwenda W, Mvalo T, Bula A, Nkhalamba L, Mofolo I, Chinula L, Thonyiwa V, Kumwenda O, Chisema MN, Hoffman IF, Miller WC, Go VF, Pence B, Squibb MA, Saidi F. Leveraging infant visit PrEP screening INtegration & tasK shifting to improve post-partum HIV prevention in Malawi (LINK): a cluster-randomized trial evaluation of a postpartum HIV prevention package among breastfeeding women in Malawi. BMC Health Serv Res. 2025 Aug 19;25(1):1107. doi: 10.1186/s12913-025-13133-6.
- 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 University of North Carolina (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.
Sarah E 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?
A study testing LINK model in people with Breastfeeding and HIV Prevention, 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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rutstein E Sarah, MD, PhD ((919) 966-2537, srutstein@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP persistence: Proportion of patients on PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days (time frame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months). The study lists 3 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 NCT06506188, which also lists 1 linked publication.
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 30 Sep 2026.