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Implementation Science at UW

Category: Funding News

Integrating expedited partner STI therapy during PrEP delivery for young women

Funding has been awarded to principal investigator Dr. Jennifer Balkus by the National Institutes of Health for "Integrating expedited partner STI therapy during PrEP delivery for young women."

 

Abstract:

Adolescent girls and young women (AGYW) in South Africa have one of the highest HIV-1 incidences globally and are a key target population for oral preexposure prophylaxis (PrEP) to prevent HIV-1 acquisition. In addition, AGYW seeking PrEP frequently experience high rates of curable sexually transmitted infections (STIs). Current South African PrEP guidelines recommend syndromic management for STIs, meaning that only women reporting symptoms will receive treatment. It is well-established that syndromic management is particularly problematic for women as the vast majority of curable STIs are asymptomatic. Persistent, untreated infections can lead to serious reproductive health outcomes, including pelvic inflammatory disease, infertility, ectopic pregnancy, neonatal infections, and increased risk HIV-1 acquisition. The high STI incidence in AGYW, which is on the rise, emphasizes the need for effective screening strategies to reduce rates of STIs and their associated impact on sexual and reproductive health outcomes.

Among women who are at risk for HIV-1 and interested in initiating PrEP, point-of-care diagnostic STI testing and expedited partner therapy (EPT) are two strategies that could have a substantial impact on STI incidence. Few studies have evaluated the feasibility and acceptability of EPT in low and middle-income countries and, to date, no studies have assessed the implementation of point-of-care STI testing and EPT in the context of PrEP scale-up.

This proposal builds on nearly a decade of collaborative HIV/STI prevention research to conduct a prospective cohort study of AGYW eligible for PrEP in South Africa in which we will assess the acceptability of point-of-care STI testing plus EPT and its impact on the incidence of common curable STIs over 12 months of follow-up (Aims 1 and 2). We will undertake qualitative interviews with participants and their male partners to identify facilitators and barriers to EPT uptake (Aim 2) and conduct a comparative cost analysis to estimate the cost per person tested using point-of-care STI testing with and without EPT incremental to the cost of standard of care (Aim 3).

Findings from the proposed research will provide essential knowledge for national policy makers to advance approaches to STI screening and treatment that will lead to reductions in STIs and improvements in AGYW sexual reproductive health. The data generated from this proposal are essential to inform efforts to reduce the burden of STIs and HIV-1 in women achieve the 2030 Sustainable Development Goals, which includes substantial reductions in HIV and STIs in key at-risk populations.

Sponsor Award Number: 1R01AI155000-01A1

mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence during Pregnancy and Breastfeeding

Funding has been awarded to principal investigator Dr. Jillian Pintye by the National Institutes of Health for "mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence during Pregnancy and Breastfeeding."

 

Abstract:

In high HIV prevalence regions, women are at high risk for HIV during pregnancy and breastfeeding. To protect women and reach elimination of mother-to-child HIV transmission, the World Health Organization recommends offering oral tenofovir (TFV)-based pre-exposure prophylaxis (PrEP) to HIV-negative pregnant and postpartum women in high-burden settings. Although most pregnant Kenyan women with HIV risk factors accept PrEP when offered, >50% discontinue PrEP within 30 days of initiation and sub-optimal adherence is common. To date, no intervention studies to improve PrEP adherence include pregnant or postpartum
women. We adapted an SMS communication platform (mWACh) to send PrEP-tailored, theory-based SMS to facilitate adherence among pregnant women who initiate PrEP. In a non-randomized pilot, we found that mWACh-PrEP recipients were more likely to persist with PrEP use and to self-report high adherence. We
propose a randomized trial to determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy through the postpartum period. We will also gather data on cost and delivery using the Proctor Implementation Outcomes Framework to expedite translation into routine practice. Our overarching hypothesis is that mWACh-PrEP will improve PrEP adherence among mothers at-risk for HIV, be acceptable to patients and providers, and be cost-effective.

By leveraging our team’s research infrastructure in Western Kenya, we are uniquely positioned to execute the following AIMS:

  • Aim 1- To determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy through the postpartum period among women who initiate PrEP within ANC-PrEP. We will conduct a 2-arm randomized trial comparing mWACh-PrEP vs standard of care (SOC, i.e. in-clinic adherence counseling) among HIV uninfected pregnant women with high HIV acquisition risk (defined by validated risk score) who initiate PrEP. The primary outcome will be adherence at 6 months postpartum (TFV hair levels >0.038 ng/mg; consistent with 7 pills/ week). Secondary outcomes will include STI incidence, adherence cofactors, and preventioneffective adherence (time-varying alignment of adherence with risk behaviors). Exploratory outcomes will include HIV incidence and perinatal outcomes by arm. Hypothesis: mWACh-PrEP will increase PrEP adherence compared to SOC.
  • Aim 2– Evaluate barriers and facilitators of mWACh-PrEP implementation within routine ANC. Using the Proctor framework, we assess acceptability and feasibility by conducting interviews and focus-groups with ANC-PrEP users, providers, and health planners. Hypothesis: Indications for readiness of mWACh-PrEP will be identified.
  • Aim 3– Estimate the cost-effectiveness of implementing mWACh-PrEP within ANC-PrEP, per HIV infection and disability-adjusted life-year (DALY) averted. We will use data from Aims 1 and conduct micro-costing and time-and-motion studies to estimate the cost of mWACh-PrEP from a payer perspective. The incremental
    cost-effectiveness ratio (ICER) per HIV infection and DALY averted compared to SOC will be calculated. Hypothesis: Incorporating data on PrEP and ANC outcomes with improve ICERs for mWACh-PrEP.

Sponsor Award Number: 1R01NR019220-01A1

Building Capacity to Address the Burden of Cardiometabolic Risk Factors and Diseases in LMICs

Funding has been awarded to principal investigator Dr. Annette Fitzpatrick by the National Institutes of Health for "Building Capacity to Address the Burden of Cardiometabolic Risk Factors and Diseases in LMICs."

 

Abstract:

An epidemiological shift from infectious to non-communicable diseases (NCDs) has led to a dramatic increase in mortality and disability over the past several decades. This has been attributed in part to important changes in lifestyles and diets, which have been described as the epidemiologic transition.
Cardiometabolic risk factors, which increase the risk of and promote onset of CVD, include a combination of metabolic dysfunctions primarily characterized by hypertension, insulin resistance, impaired glucose tolerance, dyslipidemia, and central adiposity. This crisis has led to a call for strategic investment in research including regional development, networking across countries, and expanding cross-sectoral partnerships to improve translation, innovation and patient care in low- and middle-income countries (LMICs).

In this D43 Training Application to Fogarty International Center, the University of Washington (UW) Department of Global Health will collaborate with two long-standing partners in Nepal and Kenya to address cardiometabolic diseases and risk factors through rigorous educational programs, strong mentorship and relevant research experiences. This collaboration brings together Kathmandu University (KU), with an emerging capacity to address CVD as a national priority, and University of Nairobi (UON), which has successfully implemented multiple international training programs, to provide a synergistic approach for empowering the next generation of researchers to address NCDs in these low resource settings.

Specific aims of this program are: 1) Increase high-impact research on cardiometabolic disease and risk factors by building research capacity at Kathmandu University (KU) and University of Nairobi (UN) through Master’s level degree training to include 6 clinician-researchers, 3 each from Nepal and Kenya, to study and receive UW MPH degrees; 2) Support the training of 6 students to complete an MS degree in Public Heath from KU with courses offered by D43 faculty; and 3) Provide mid- and short-term
training in Kenya and Nepal focusing on essential research and leadership skills including a one-year certificate program using on-line distance learning resulting in culminating projects, and in-country workshops offered by UW, KU and UON Core faculty. Conferences that bring together members of the NCD community with KU and UON researchers and county health directors will be offered to promote community engagement in local care, treatment and prevention in both LMICs.

Using UW’s well-established approaches to training, this program will establish greatly needed implementation science research capacity at KU and UON and contribute to changing the face of the NCD epidemic in LMICs.

Sponsor Award Number: 1D43TW011596-01