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Prevention study for Breastfeeding
Official title Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
ClinicalTrials.gov ID: NCT06506188
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 99. Healthy volunteers may be eligible.
You may be able to join if
- PrEP user cohort: PrEP user cohort includes all adolescent and adult women \>=15 years old who are on PrEP and breastfeeding, enrolled in PrEP at...
- Female enrolled in PrEP care at a study site
- Breastfeeding documented while on PrEP
- Living without HIV
You likely can't join if
- \- None PrEP user survey and dried blood spot sub-group Breastfeeding women 15 years and older who are presenting \~6 months after initiating PrEP...
- 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 Exclusion criteria: \- Decline informed consent Postpartum women - health passport review We review use existing health records...
- Female presenting for child vaccination to participating clinical site
- Aged15 years and older (assent with parental/guardian consent for women aged 15-17) Exclusion criteria: \- Decline informed consent Non-patient key...
See the full eligibility criteria
- PrEP user cohort: PrEP user cohort includes all adolescent and adult women \>=15 years old who are on PrEP and breastfeeding, enrolled in PrEP at each of the participating 12 sites during the study follow-up period...
- Female enrolled in PrEP care at a study site
- Breastfeeding documented while on PrEP
- Living without HIV
- \- 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...
- 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 Exclusion criteria: \- Decline informed consent Postpartum women - health passport review We review use existing health records (Health passports) of postpartum women presenting to infant immunization...
- Female presenting for child vaccination to participating clinical site
- Aged15 years and older (assent with parental/guardian consent for women aged 15-17) Exclusion criteria: \- Decline informed consent Non-patient key stakeholder Non-patient stakeholders relevant to intervention...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Lilongwe, Malawi
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lilongwe, Malawi. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.