Not All Are Lost: Interrupted Laboratory Monitoring, Early Death, and Loss to Follow-Up (LTFU) in a Large South African Treatment Program

Background: Many HIV treatment programs in resource-limited settings are plagued by high rates of loss to follow-up (LTFU). Most studies have not distinguished between those who briefly interrupt, but return to care, and those more chronically lost to follow-up. Methods: We conducted a retrospective cohort study of 11,397 adults initiating antiretroviral therapy (ART) in 71 Southern African Catholic Bishops Conference/Catholic Relief Services HIV treatment clinics between January 2004 and December 2008. We distinguished among patients with early death, within the first 7 months on ART; patients with interruptions in laboratory monitoring (ILM), defined as missing visits in the first 7 months on ART, but returning to care by 12 months; and those LTFU, defined as missing all follow-up visits in the first 12 months on ART. We used multilevel logistic regression models to determine patient and clinic-level characteristics associated with these outcomes. Results: In the first year on ART, 60% of patients remained in care, 30% missed laboratory visits, and 10% suffered early death. Of the 3,194 patients who missed laboratory visits, 40% had ILM, resuming care by 12 months. After 12 months on ART, patients with ILM had a 30% increase in detectable viremia compared to those who remained in care. Risk of LTFU decreased with increasing enrollment year, and was lowest for patients who enrolled in 2008 compared to 2004 [OR 0.49, 95%CI 0.39–0.62]. Conclusions: In a large community-based cohort in South Africa, nearly 30% of patients miss follow-up visits for CD4 monitoring in the first year after starting ART. Of those, 40% have ILM but return to clinic with worse virologic outcomes than those who remain in care. The risk of chronic LTFU decreased with enrollment year. As ART availability increases, interruptions in care may become more common, and should be accounted for in addressing program LTFU

Lessons for strengthening childhood immunization in low- and middle-income countries from a successful public-private partnership in rural Nigeria

BACKGROUND: Immunization is a cost-effective public health strategy to reduce vaccine preventable disease, especially in childhood. METHODS: This paper reports the philosophy, service delivery, achievements and lessons learned from an immunization program in rural Nigeria privately financed via a corporate social responsibility initiative from GlaxoSmithKline Biologicals. RESULTS: The immunization program served the community for a 16-y period extending from 1998 until 2015, resulting in an increase in age-appropriate immunization coverage from 43% to 78%. CONCLUSION: In its success, this immunization program exemplified the importance of early and sustained community engagement, integration of strategies to optimize implementation outcomes and effective team building well before some of these principles were accepted and codified in the literature. The project also underscores the important role that the private sector can bring to achieving critical immunization goals, especially among underserved populations and provides a model for successful public-private partnership

The impact of user fees on uptake of HIV services and adherence to HIV treatment: Findings from a large HIV program in Nigeria.

BackgroundGlobal HIV funding cutbacks have been accompanied by the adoption of user fees to address funding gaps in treatment programs. Our objective was to assess the impact of user fees on HIV care utilization and medication adherence in Nigeria.MethodsWe conducted a retrospective analysis of patients enrolled in care before (October 2012-September 2013) and after (October 2014-September 2015) the introduction of user fees in a Nigerian clinic. We assessed pre- vs. post-user fee patient characteristics and enrollment trends, and determined risk of care interruption, loss to follow-up, and optimal medication adherence.ResultsAfter fees were instituted, there was a 66% decline in patient enrollment and 75% decline in number of ART doses dispensed. There was no difference in the proportion of female clients (64% vs 63%, p = 0.46), average age (36 vs. 37 years, p = 0.15), or median baseline CD4 (220/ul vs. 222/uL, p = 0.24) in pre- and post-fee cohorts. There was an increase in clients employed and/or had tertiary education (24% vs. 32%, pConclusionsPatients enrolled in care after introduction of user fees in Nigeria were more likely to be educated or employed, and effectively retained in care after starting ART. However, fees were accompanied by a drastic reduction in new patient enrollment, suggesting that many patients may have been marginalized from HIV care

Effect of PEPFAR funding policy change on HIV service delivery in a large HIV care and treatment network in Nigeria.

The transition to PEPFAR 2.0 with its focus on country ownership was accompanied by substantial funding cuts. We describe the impact of this transition on HIV care in a large network of HIV clinics in Nigeria. We surveyed 30 comprehensive HIV treatment clinics to assess services supported before (October 2013-September 2014) and after (October 2014-September 2015) the PEPFAR funding policy change, the impact of these policy changes on service delivery areas, and response of clinics to the change. We compared differences in support for staffing, laboratory services, and clinical operations pre- and post-policy change using paired t-tests. We used framework analysis to assess answers to open ended questions describing responses to the policy change. Most sites (83%, n = 25) completed the survey. The majority were public (60%, n = 15) and secondary (68%, n = 17) facilities. Clinics had a median of 989 patients in care (IQR: 543-3326). All clinics continued to receive support for first and second line antiretrovirals and CD4 testing after the policy change, while no clinics received support for other routine drug monitoring labs. We found statistically significant reductions in support for viral load testing, staff employment, defaulter tracking, and prevention services (92% vs. 64%, p = 0.02; 80% vs. 20%, 100% vs. 44%, 84% vs. 16%, respectively, p<0.01 for all) after the policy change. Service delivery was hampered by interrupted laboratory services and reduced wages and staff positions leading to reduced provider morale, and compromised quality of care. Almost all sites (96%) introduced user fees to address funding shortages. Clinics in Nigeria are experiencing major challenges in providing routine HIV services as a result of PEPFAR's policy changes. Funding cutbacks have been associated with compromised quality of care, staff shortages, and reliance on fee-based care for historically free services. Sustainable HIV services funding models are urgently needed

PEERNaija—a mobile health platform incentivizing medication adherence among youth living with HIV in Nigeria: study protocol for a randomized controlled trial

Abstract Background Poor medication adherence is a major barrier to HIV control among youth living with HIV (Y-PLWH). The PEERNaija application (app) is an adapted smartphone app grounded in social cognitive and contigency management theories and designed to harness peer-based social incentives and conditional financial incentives to promote medication adherence. The app delivers a multifaceted medication adherence intervention including (1) peer-based social incentives, (2) financial incentives, (3) virtual peer social support, and (4) early clinic-based outreach for non-adherent Y-PLWH. A pilot trial of the app will be conducted in Nigeria, Africa’s most populous country with the 4th largest HIV epidemic, and home to 10% of the world’s four million Y-PLWH. Methods In this randomized controlled trial, we will compare implementation outcomes (feasibility, acceptability, appropriateness measured via validated scales, enrollment and application installation rates, feedback surveys and focus group discussions with participants, and back-end application data), and preliminary efficacy (in improving medication adherence and viral suppression) of the PEERNaija app at 6 months. Participants in Arm 1 (PEERNaija) will receive daily medication reminders, peer-based social incentives, and virtual peer social support. Participants in Arm 2 (PEERNaija +) will additionally receive a conditional financial incentive based on their adherence performance. Eligibility for Y-PLWH includes (1) being aged 14–29 years, (2) being on ART, (3) owning a smartphone, (4) being willing to download an app, and (5) being able to read simple text in English. Discussion This study will serve as the basis for a larger intervention trial evaluating the PEERNaija app (and the integration of mHealth, incentive, and peer-support-based strategies) to improve HIV outcomes in a critically important region of the world for Y-PLWH. Trial registration ClinicalTrials.gov. NCT04930198. First submitted date: May 25, 2021. Study start: August 1, 2021, https://clinicaltrials.gov/ . Protocol version: January 21, 2022

Trends in LTFU and program size in the Catholic Relief Services/Southern African Catholic Bishops Conference HIV treatment program, 2004–2008.

<p>Trends in LTFU and program size in the Catholic Relief Services/Southern African Catholic Bishops Conference HIV treatment program, 2004–2008.</p

Summary of patient outcomes in a cohort study of LTFU in a large South African ART program.

<p>Summary of patient outcomes in a cohort study of LTFU in a large South African ART program.</p

Factors associated with interrupted laboratory monitoring, LTFU, and early death in multivariate analysis^*.

<p>LTFU: Loss to Follow Up, ART: Antiretroviral Therapy, OR: Odds Ratio,</p><p>*all models adjusted for all variables listed in table.</p