Document text
Principal Investigator: Tessa Leigh Concepcion
Organization: UNIVERSITY OF WASHINGTON
Fiscal Year: 2024
Award: $43,050
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
ABSTRACT
This F31 proposal aims to evaluate pregnant and postpartum women’s preferences for different pre-exposure
prophylaxis (PrEP) methods and identify early process indicators for implementing these options in maternal and
child health (MCH) systems. HIV incidence remains unacceptability high among adolescent girls and young
women (AGYW) in East and Southern Africa and evidence suggests a two-fold higher risk of HIV acquisition
during pregnancy. Daily oral PrEP is scaling up for pregnant/postpartum women in Kenya but despite appreciable
uptake of oral PrEP by pregnant/postpartum women, >50% discontinue within 30 days of initiation. Unique
attributes of pregnancy and postpartum may influence discontinuation, including co-occurring side effects (e.g.,
nausea) and demands of motherhood. New long-acting (LA)-PrEP methods (e.g., vaginal rings and injectables)
have recently been approved and may address some barriers to PrEP persistence during pregnancy/postpartum,
though no systemic evaluation has been conducted to date. Early implementation studies for LA-PrEP can
accelerate its integration into maternal and child health (MCH) systems. Kenya, as one of the first countries to
implement PrEP at scale, is an ideal setting to study expanding access and uptake among pregnant women.
This proposal leverages data collected in an ongoing RCT (MR01NR019220, MPI: Pintye, Kinuthia) among 600
Kenyan women who initiate daily oral PrEP during pregnancy and are followed through nine months postpartum.
The study includes longitudinal assessments of preferences for PrEP methods (pills, vaginal rings, injectables).
Interviews and focus-groups are also conducted among PrEP users, providers, and PrEP stakeholders to
ascertain implementation outcomes. In Aim 1, we will determine pregnant and postpartum women’s preferred
PrEP attributes for HIV prevention-effective use applying discrete choice experiment analysis methods to identify
preferred PrEP method. In Aim 2, we will identify profiles of pregnant/postpartum women who would prefer novel
PrEP methods using latent class models to identify distinct profiles of study participants with different preferences
for several PrEP methods (daily oral, vaginal ring, injectable) and the driving predictors of preference within these
classes. In Aim 3, we will evaluate implementation determinants for integration of LA-PrEP formulations into
MCH systems using qualitative research informed by an implementation science process framework. The
proposed research plan will provide the F31 candidate rigorous predoctoral training in 1) analytic techniques in
discrete choice experiments and latent class modeling, 2) measurement of social and structural determinants of
HIV risk for pregnant/postpartum women, and 3) application of a process framework for implementation of LA-
PrEP. This study will be the first evaluation of user-preferences for new PrEP methods among pregnant and
postpartum women and findings will help inform messaging and introduction of novel PrEP agents tailored to
this important population. This F31 will provide rigorous implementation science training, expertise in maternal
HIV prevention, and opportunities for future implementation research in this unique and understudied population.
Terms: <AIDS Virus><AIDS prevention><Acceleration><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Address><Adherence><Age><Assess implementation><Automobile Driving><Characteristics><Clinical><Code><Coding System><Country><County><Data><Dose><Early identification><Economic Income><Economical Income><Effectiveness><Evaluation><Exploration, Preparation, Implementation, and Sustainability><Exploration, Preparation, Implementation, and Sustainment><Face><Family Sizes><Female Adolescents><Focus Groups><Formulation><Frequencies><Gestation><Goals><HIV><HIV Prevention><HIV risk><HIV/AIDS prevention><Health><Health system><High Risk Woman><Human Immunodeficiency Viruses><Implementation assessment><Incidence><Income><Injectable><Interview><Investigators><Kenya><LAV-HTLV-III><Lymphadenopathy-Associated Virus><Maps><Maternal and Child Health><Measurement><Methods><Modality><Modeling><Nausea><Oral><Parents><Participant><Perinatal><Peripartum><Population><Position><Positioning Attribute><Post-partum Women><Postpartum Period><Postpartum Women><PrEP><Pregnancy><Pregnant Women><Preventative strategy><Prevention><Prevention Research><Prevention strategy><Preventive strategy><Process><Prospective cohort><Provider><Qualitative Research><Research><Research Personnel><Researchers><Southern Africa><Symptoms><Techniques><Training><Transcript><Transmission><Vaginal Ring><Vertical Transmission><Virus-HIV><Visit><Woman><Work><access to health care><access to healthcare><accessibility of health care><accessibility to health care><accessibility to healthcare><adolescent girl><after pregnancy><ages><at-risk females><at-risk women><driving><effectiveness-implementation RCT><effectiveness-implementation randomized control trial><effectiveness-implementation randomized controlled trial><effectiveness/implementation hybrid><evaluate implementation><evaluation of implementation><expectant mother><expecting mother><experience><experiment><experimental analysis><experimental research><experimental study><experiments><faces><facial><females at high risk><forgiveness><formative assessment><formative evaluation><future implementation><health care access><health care availability><health care service access><health care service availability><healthcare access><healthcare accessibility><healthcare availability><healthcare service access><healthcare service availability><high risk><high risk females><implementation determinants><implementation evaluation><implementation factors><implementation framework><implementation outcomes><implementation process><implementation research><implementation research framework><implementation science><implementation science framework><implementation study><improved><incomes><informant><intravaginal ring><motherhood><novel><parent><perinatal period><perinatal phase><pill><post pregnancy><post-partum><pre-doc><pre-doctoral><pre-exposure prophylaxis><predoctoral><preference><pregnant mothers><scale up><side effect><social><social determinants><sociodeterminant><structural determinants><structural factors><transmission process><uptake><women at high risk><young woman>