The goal of this clinical trial is to find better ways to care for pregnant and postpartum adolescent girls and young women (AGYW) aged 15-24 years with HIV in Tanzania, and to prevent them from passing HIV to their babies. The main questions it aims to answer are:
* How often do young pregnant women with HIV go to their health appointments and stay on their treatment up to two years after giving birth? * How many babies born to young women with HIV stay HIV-free for two years? * How soon do young women with HIV get pregnant again after giving birth, and what factors affect this? * What are the best ways to help young women with HIV stay in care and stay healthy during and after pregnancy? * What social and structural factors affect whether young pregnant women with HIV go to their health appointments and stay on their treatment? * How can we work with young women with HIV to create and test a package of interventions to improve their healthcare during and after pregnancy? * Can this package of interventions help young women with HIV stay in care and remain healthy during and after pregnancy?
Participants will:
* Have their health data analyzed via health service records of all women who received HIV prevention services between 2018 and 2020, and were followed until 2023, across 559 health facilities in Tanzania. * Participate in qualitative interviews to share their experiences and challenges with staying in care. * Help to co-create a package of interventions to improve care. * Take part in a cluster-randomized trial to test these interventions. Researchers will compare the outcomes of the intervention package to see if they improve care engagement, retention, and health outcomes for AGYW with HIV during and after pregnancy.
Pregnant/postpartum adolescent girls and young women (AGYW) with HIV aged 15-24 years, who started PMTCT services between January 1, 2018, and December 31, 2020.
Infants born to the included AGYW during this period.
AGYW whose ART (Antiretroviral Therapy) status was not recorded.
Women who had not started ART.
AGYW living with HIV who are currently pregnant, previously pregnant/postpartum, and never pregnant).
HCPs (Health Care Providers) at clinics providing PMTCT services.
Single group
Co-produced intervention to optimize PMTCT care engagement
BehavioralWhile the specific interventions package will developed earlier in the project, it may include evidence-based approaches such as peer mentor mothers, male partner involvement, flexible hours for girls/young women and mobile phone reminders. Overall, the interventions should be brief and easy to integrate into standard care, aiming to 'nudge' or motivate participants (towards improved engagement, retention, and outcomes) as well as health care providers or community stakeholders to better understand and support girls/young women\'s specific needs. A focal team of 2-3 persons will be trained and engaged to drive the implementation of the interventions at randomized faciltiies. The focal team will orient and engage other staff and stakeholders to deliver the interventions, identify and address gaps, and monitor implementation fidelity and quality using standard operating procedures.
Time to ART attrition
The hazard rate of discontinuing ART for any reason including death, stopping ART or loss to follow-up for 90 consecutive days from scheduled appointment
Detectable viral load
The proportion of participants with detectable viral load, defined as ≥50 viral copies/mL of blood after at least three months of ART use (for those who started ART at enrolment) or detectable VL after enrolment (for those already on ART at enrolment).
HIV-free infant survival
Defined as the proportion of infant who are alive and tested negative at final HIV test by 18+ months postpartum, or last available data point
Repeat pregnancy
Defined as the number of subsequent pregnancies occurring after the index pregnancy (at PMTCT enrolment) during the two years of post-partum follow-up period
Uptake of PMTCT services
Rate of uptake of PMTCT services in-line with national PMTCT guidelines, defined as (in relation to the index pregnancy): starting ART before/within the first trimester, making at least 8 visits before delivery, and receiving first infant HIV testing within 2 months postpartum.
Maternal/pregnancy loss
The proportion of participants ending in a maternal or pregnancy loss in relation to the index pregnancy, defined as miscarriage, stillbirth or maternal death.
Acceptability
Qualitative themes related to acceptability of the intervention, based on thematic analysis of qualitative data from individual interviews with participants
Intervention feasibility
Qualitative themes related to feasibility of the intervention based on qualitative data collected during individual interviews
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Karolinska Institutet
Lead sponsor
Management and Development for Health, Tanzania
Collaborator
