Implementation determinants and strategies in integration of PrEP into maternal and child health and family planning services: experiences of frontline healthcare workers in Kenya

BackgroundDelivery of PrEP to adolescent girls and young women (AGYW) and to pregnant women through maternal and child health (MCH) and family planning (FP) clinics is scaling up in Kenya. Evaluation of implementation challenges and strategies is critical to optimize delivery.MethodsWe conducted focus group discussions (FGDs) with healthcare workers (HCWs) in MCH and FP clinics offering PrEP in a large implementation project in Kisumu, Kenya. Discussion guides were based on the Consolidated Framework for Implementation Research (CFIR). FGDs were audio recorded and transcribed. Directed content analysis was used to identify implementation challenges and strategies to overcome them.ResultsFifty HCWs from 26 facilities participated in 8 FGDs. HCWs believed PrEP integration was appropriate because it met the needs of AGYW and pregnant women by providing a female-controlled prevention strategy and aligned with policy priorities of elimination of vertical HIV transmission. They were universally accepting of PrEP provision, especially through MCH clinics, noting the relative advantage of this approach because it: (1) enabled high coverage, (2) harmonized PrEP and MCH visits, and (3) minimized stigma compared to PrEP offered through HIV care clinics. However, HCWs noted implementation challenges affecting feasibility and adoption including: (1) increased workload and documentation burden amid workforce shortages, (2) insufficient health care worker knowledge (3) multiple implementing partners with competing priorities (4) drug and documentation form stockouts. HCWs employed various implementation strategies to overcome challenges, including task shifting from nurses to HIV testing providers, patient flow modifications (e.g., fast-tracking PrEP clients to reduce wait times), PrEP demand generation and myth clarification during health talks, provider education, dedicated PrEP delivery rooms, and coordination with adolescent-friendly services. Additional suggested strategies to improve PrEP integration included community education to increase broader PrEP awareness and enable shorter counseling sessions, and task-shifting data entry and client risk assessments.ConclusionsHCWs were enthusiastic about the appropriateness and acceptability of integrating PrEP services into MCH and FP clinics but noted challenges to adoption and feasibility. Strategies to address challenges focused on improving provider time and space constraints, and increasing provider and client knowledge

From Bench to Bedside: Understanding Multiple Dimensions of Pediatric HIV in Kenya

Thesis (Ph.D.)--University of Washington, 2013Introduction: Globally, over 3.3 million children are infected with HIV. Despite significant progress, there is a need to better understand mechanisms for transmission and progression of HIV in children. In addition, among children receiving HIV care, it is important to determine the best ways to inform them about their diagnosis. Methods: Consistent with the University of Washington Public Health Genetics PhD requirement of including both genetic epidemiology and social/cultural domains, this PhD dissertation addresses two projects of relevance to children with HIV. The aim of the first project is to determine the role of selected genetic mechanisms influencing pediatric HIV acquisition and progression. The aim of the second project is to determine how, when and what healthcare providers decide to tell HIV-infected children about their diagnosis. For project 1, we used genetic epidemiology methods to evaluate the role of variations in innate immune system genes on infant HIV acquisition and progression in a Kenyan mother-to-child transmission (MTCT) cohort. Specifically, we genotyped infants from this cohort for 6 candidate and 118 haplotype-tagging polymorphisms in TLRs 2, 3, 4, 7, 8, and 9, MyD88 and TIRAP, and 144 ancestral informative markers. Cox proportional hazards and linear regression were performed to assess TLR polymorphism associations with HIV acquisition, peak HIV RNA levels, and infant mortality. Sex-stratified analyses of TLR7 and TLR8 were conducted due to their X-chromosome location and Bonferroni methods were used to account for multiple comparisons. For project 2, we used qualitative methods to analyze transcripts from semi-structured interviews conducted with 21 healthcare providers caring for HIV-infected children from 5 clinics in Kenya. Interview transcripts were systematically coded and conceptually analyzed using modified grounded theory and directed content analysis approaches. Resulting themes were identified related to the disclosure processes, ethical and practical rationale for different approaches, and challenges or barriers to disclosure. Results: For project 1, we found that TLR variants influenced HIV acquisition and progression. Infants with the TLR9 1635A (rs352140) variant were more likely to acquire HIV by 1 month of age (HR=1.81, 95% CI: 1.05, 3.14; p=0.033) and 12 months of age (HR=1.62, 95% CI: 1.01, 2.60; p=0.044). We also found that among 56 infants infected by 1 month of age, the TLR9 1635A allele was associated with a decrease in peak viral load (-0.58 log10 c/ml, 95% CI: -0.95, -0.22; p=0.002) whereas female infants with the TLR8 1G (rs3764880) variant had increased peak viral load (0.78 log10 c/ml, 95% CI: 0.35, 1.21; p<0.001). We also found that among female infants infected at less than 1 year of age, infants with the TLR7 rs1634319 C allele had higher peak viral load (0.80 log10 c/ml, 95% CI: 0.40, 1.20; corrected p=0.027). For project 2, we found that all health care providers interviewed believed early, supported disclosure to children is important and cited concerns for the child's health and well-being as the central rationale. Providers viewed disclosure as a longitudinal process and advocated tailoring the approach to the individual child. Providers observed that preparation, support after disclosure, and a child's personality are more relevant predictors of the impact of disclosure on the child and family than the age when diagnosis is revealed. All stressed the need to incorporate caregiver preparation and empowerment and recognized that significant barriers to disclosure included caregiver fears about child reactions, including judgment of the parent. Conclusions: We found that variations in TLRs influence HIV acquisition and progression in infants. These associations may inform novel vaccine and therapeutic strategies for pediatric HIV. Our observations among health care providers revealed a wealth of clinical approaches that can be used in guidelines to improve pediatric HIV disclosure. Better understanding the mechanisms influencing infection and how to care for HIV-infected children can help reduce the global burden of this disease

Estimating the costs of adolescent HIV care visits and an intervention to facilitate transition to adult care in Kenya.

IntroductionAdolescents with HIV in sub-Saharan Africa face challenges transitioning to adult HIV care, which can affect long-term HIV care adherence and retention. An adolescent transition package (ATP) focused on transition tools can improve post-transition clinical outcomes, but its implementation costs are unknown.MethodsWe estimated the average cost per patient of an HIV care visit and ATP provision to adolescents. Data was collected from 13 HIV clinics involved in a randomized clinical trial evaluating ATP in western Kenya. We conducted a micro-costing and activity-driven time estimation to assess costs from the provider perspective. We developed a flow-map, conducted staff interviews, and completed time and motion observation. ATP costs were estimated as the difference in average cost for an HIV care transition visit in the intervention compared to control facilities. We assessed uncertainty in costing estimates via Monte Carlo simulations.ResultsThe average cost of an adolescent HIV care visit was 29.8USD (95%CI 27.5, 33.4) in the standard of care arm and 32.9USD (95%CI 30.5, 36.8) in the ATP intervention arm, yielding an incremental cost of 3.1USD (95%CI 3.0, 3.4) for the ATP intervention. The majority of the intervention cost (2.8USD) was due ATP booklet discussion with the adolescent.ConclusionThe ATP can be feasibly implemented in HIV care clinics at a modest increase in overall clinic visit cost. Our cost estimates can be used to inform economic evaluations or budgetary planning of adolescent HIV care interventions in Kenya

Debrief Reports to Expedite the Impact of Qualitative Research: Do They Accurately Capture Data from In-depth Interviews?

"Debrief reports" (DRs) use structured forms to capture key concepts from in-depth interviews and focus group discussions. They are completed by interviewers and rapidly disseminated to key team members to facilitate identification of potential problems with study procedures, recruitment, or participant engagement and to inform critical adjustments, which can be especially pertinent in intervention studies. Their reliability and validity have yet to be formally evaluated. To assess the accuracy of DRs in capturing key content, raters analyzed a random sub-sample of 20 pairs of de-identified transcripts and their linked DRs from the VOICE-D trial. Analyses generally supported the accuracy of DRs; however, pertinent information from transcripts was occasionally missed or recorded with discrepancies or lack of detail. Longer transcripts and DR sections describing complex topic areas were more likely to involve discrepancies. Recommendations are offered for further research and optimizing the use of DRs

“Sign Me Up”: a qualitative study of video observed therapy (VOT) for patients receiving expedited methadone take-homes during the COVID-19 pandemic

Abstract Background Federal and state regulations require frequent direct observation of methadone ingestion at an Opioid Treatment Program (OTP)—a requirement that creates barriers to patient access. Video observed therapy (VOT) may help to address public health and safety concerns of providing take-home medications while simultaneously reducing barriers to treatment access and long-term retention. Evaluating user experiences with VOT is important for understanding the acceptability of this strategy. Methods We conducted a qualitative evaluation of a clinical pilot program of VOT via smartphone that was rapidly implemented between April and August 2020 during the COVID-19 pandemic within three opioid treatment programs. In the program, selected patients submitted video recordings of themselves ingesting methadone take-home doses, which were asynchronously reviewed by their counselor. We recruited participating patients and counselors for semi-structured, individual interviews to explore their VOT experiences after program completion. Interviews were audio recorded and transcribed. Transcripts were analyzed using thematic analysis to identify key factors influencing acceptability and the effect of VOT on the treatment experience. Results We interviewed 12 of the 60 patients who participated in the clinical pilot and 3 of the 5 counselors. Overall, patients were enthusiastic about VOT, noting multiple benefits over traditional treatment experiences, including avoiding frequent travel to the clinic. Some noted how this allowed them to better meet recovery goals by avoiding a potentially triggering environment. Most appreciated having increased time to devote to other life priorities, including maintaining consistent employment. Participants described how VOT increased their autonomy, allowed them to keep treatment private, and normalized treatment to align with other medications that do not require in-person dosing. Participants did not describe major usability issues or privacy concerns with submitting videos. Some participants reported feeling disconnected from counselors while others felt more connected. Counselors felt some discomfort in their new role confirming medication ingestion but saw VOT as a useful tool for select patients. Conclusions VOT may be an acceptable tool to achieve equipoise between lowering barriers to treatment with methadone and protecting the health and safety of patients and their communities

Does HIV index testing bring patients into treatment at earlier stages of HIV disease? Results from a retrospective study in Ukraine

Abstract Background Over one-third of people living with HIV (PLH) in Ukraine are not on treatment. Index testing services, which link potentially exposed partners (named partners) of known PLH (index patients) with testing and treatment services, are being scaled in Ukraine and could potentially close this gap. Methods This retrospective study included patient data from 14,554 adult PLH who initiated antiretroviral treatment (ART) between October 2018 and May 2021 at one of 35 facilities participating in an intervention to strengthen index testing services. Mixed effects modified Poisson models were used to assess differences between named partners and other ART initiators, and an interrupted time series (ITS) analysis was used to assess changes in ART initiation over time. Results Compared to other ART initiators, named partners were significantly less likely to have a confirmed TB diagnosis (aRR = 0.56, 95% CI = 0.40, 0.77, p < 0.001), a CD4 count less than 200 cells/mm3 (aRR = 0.84, 95% CI = 0.73, 0.97, p = 0.017), or be categorized as WHO HIV stage 4 (aRR = 0.68, 9% CI = 0.55, 0.83, p < 0.001) at the time of ART initiation, and were significantly more likely to initiate ART within seven days of testing for HIV (aRR = 1.36, 95% CI = 1.22, 1.50, p < 0.001). Our ITS analysis showed a modest 2.34% (95% CI = 0.26%, 4.38%; p = 0.028) month-on-month reduction in mean ART initiations comparing the post-intervention period to the pre-intervention period, although these results were likely confounded by the COVID epidemic. Conclusion Our findings suggest that index testing services may be beneficial in bringing PLH into treatment at an earlier stage of HIV disease and decreasing delays between HIV testing and ART initiation, potentially improving patient outcomes and retention in the HIV care cascade

The role of male partners in women’s participation in research during pregnancy: a case study from the partners demonstration project

Abstract The exclusion of pregnant women from health research remains a significant challenge globally. In settings where cultural traditions and gender norms support a more restricted decision-making role for women in general, little is known about the attitudes of male partners toward the inclusion of women in research during pregnancy. Understanding the expectations of both men and women in such cultural settings offers an opportunity to engage and address local ethical concerns to improve women’s access to research during pregnancy and enhance intervention development. In this paper, we present a qualitative research ethics case study, drawn from the Partners Demonstration Project of pre-exposure prophylaxis (PrEP) in Kenya, regarding the role of male partners in decision-making to continue PrEP during pregnancy. PrEP is an effective HIV prevention tool; however, since pregnant women were excluded from early PrEP clinical trials, safety and efficacy data during pregnancy are limited. Given continued high rates of HIV infection for women, some pregnant women are now being provided with PrEP or are involved in PrEP research. Men and women in our study were equally concerned about the health risks of PrEP to the fetus and depended on healthcare provider guidance to understand these risks. Because the demonstration project enrolled couples, an implicit social expectation for many women’s continuation of PrEP during pregnancy was consultation with male partners. Some women reported that consenting to participate was exclusively a woman’s decision; however, many reported that they deferred to their male partner’s opinion and support during the decision-making process. Most male partners believed women should not participate in research studies without their partner’s permission, while a few men believed participation was ultimately a woman’s decision. We suggest that relational autonomy can support a middle ground for informed consent that promotes women’s autonomy while accommodating partner engagement

Fig 2 -

Distribution of activities by role in control (A) and intervention (B) facilities.</p

Time-motion instrument: Estimated times per activity.

Time-motion instrument: Estimated times per activity.</p