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: Introduction: In South Africa, the HIV care cascade remains suboptimal. We investigated the impact of small conditional financial incentives (CFIs) and male‐targeted HIV‐specific decision‐support application (EPIC‐HIV) on the HIV care cascade. Methods: In 2018, in uMkhanyakude district, 45 communities were randomly assigned to one of four arms: (i) CFI for home‐based HIV testing and linkage to care within 6 weeks (R50 [US$3] food voucher each); (ii) EPIC‐HIV which are based on self‐determination theory; (iii) both CFI and EPIC‐HIV; and (iv) standard of care. EPIC‐HIV consisted of two components: EPIC‐HIV 1, provided to men through a tablet before home‐based HIV testing, and EPIC‐HIV 2, offered 1 month later to men who tested positive but had not yet linked to care. Linking HITS trial data to national antiretroviral treatment (ART) programme data and HIV surveillance programme data, we estimated HIV status awareness after the HITS trial implementation, ART status 3 month after the trial and viral load suppression 1 year later. Analysis included all known individuals living with HIV in the study area including those who did not participated in the HITS trial. Results: Among the 33,778 residents in the study area, 2763 men and 7266 women were identified as living with HIV by the end of the intervention period and included in the analysis. After the intervention, awareness of HIV‐positive status was higher in the CFI arms compared to non‐CFI arms (men: 793/908 [87.3%] vs. 1574/1855 [84.9%], RR = 1.03 [95% CI: 0.99−1.07]; women: 2259/2421 [93.3%] vs. 4439/4845 [91.6%], RR = 1.02 [95% CI: 1.00−1.04]). Three months after the intervention, no differences were found for linkage to ART between arms. One year after the intervention, only 1829 viral test results were retrieved. Viral suppression was higher but not significant in the EPIC‐HIV intervention arms among men (65/99 [65.7%] vs. 182/308 [59.1%], RR = 1.11 [95% CI: 0.88−1.40]). Conclusions: Small CFIs can contribute to achieve the first step of the HIV care cascade. However, neither CFIs nor EPIC‐HIV was sufficient to increase the number of people on ART. Additional evidence is needed to confirm the impact of EPIC‐HIV on viral suppression., INTRODUCTION Despite progress towards UNAIDS's 95‐95‐95, the number of people living with HIV (PLHIV) aware of their HIV status or on antiretroviral treatment (ART) remains insufficient in South Africa [1]. [...]

: Introduction: While it is widely acknowledged that family relationships can influence health outcomes, their impact on the uptake of individual health interventions is unclear. In this study, we quantified how the efficacy of a randomized health intervention is shaped by its pattern of distribution in the family network. Methods: The “Home‐Based Intervention to Test and Start” (HITS) was a 2×2 factorial community‐randomized controlled trial in Umkhanyakude, KwaZulu‐Natal, South Africa, embedded in the Africa Health Research Institute's population‐based demographic and HIV surveillance platform (ClinicalTrials.gov # NCT03757104). The study investigated the impact of two interventions: a financial micro‐incentive and a male‐targeted HIV‐specific decision support programme. The surveillance area was divided into 45 community clusters. Individuals aged ≥15 years in 16 randomly selected communities were offered a micro‐incentive (R50 [$3] food voucher) for rapid HIV testing (intervention arm). Those living in the remaining 29 communities were offered testing only (control arm). Study data were collected between February and November 2018. Using routinely collected data on parents, conjugal partners, and co‐residents, a socio‐centric family network was constructed among HITS‐eligible individuals. Nodes in this network represent individuals and ties represent family relationships. We estimated the effect of offering the incentive to people with and without family members who also received the offer on the uptake of HIV testing. We fitted a linear probability model with robust standard errors, accounting for clustering at the community level. Results: Overall, 15,675 people participated in the HITS trial. Among those with no family members who received the offer, the incentive's efficacy was a 6.5 percentage point increase (95% CI: 5.3−7.7). The efficacy was higher among those with at least one family member who received the offer (21.1 percentage point increase (95% CI: 19.9−22.3). The difference in efficacy was statistically significant (21.1–6.5 = 14.6%; 95% CI: 9.3−19.9). Conclusions: Micro‐incentives appear to have synergistic effects when distributed within family networks. These effects support family network‐based approaches for the design of health interventions., INTRODUCTION Though family relationships crucially determine health and wellbeing, their role in shaping the uptake of individual health interventions is not well‐understood. Using family network data from a large population‐based [...]

Background Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa. Methods and findings We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were [greater than or equal to]18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic-time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention. Conclusions We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success. Trial registration This trial is registered at ClinicalTrials.gov under registration number NCT02626351., Author(s): H. Manisha Yapa 1,2,*, Jan-Walter De Neve 3, Terusha Chetty 4, Carina Herbst 2, Frank A. Post 5, Awachana Jiamsakul 1, Pascal Geldsetzer 3,6, Guy Harling 2,7, Wendy Dhlomo-Mphatswe [...]

Background: We evaluated continuous quality improvement (CQI) targeting antenatal HIV care quality in rural South Africa using a stepped-wedge cluster-randomised controlled trial (Management and Optimisation of Nutrition, Antenatal, Reproductive, Child health, MONARCH) and an embedded process evaluation. Here, we present results of the process evaluation examining determinants of CQI practice and 'normalisation.' Methods: A team of CQI mentors supported public-sector health workers in seven primary care clinics to (1) identify root causes of poor HIV viral load (VL) monitoring among pregnant women living with HIV and repeat HIV testing among pregnant women not living with HIV, and (2) design and iteratively test their own solutions. We used a mixed methods evaluation with field notes from CQI mentors ('dose' and 'reach' of CQI, causes of poor HIV care testing rates, implemented change ideas); patient medical records (HIV care testing by clinic and time step); and semi-structured interviews with available health workers. We analysed field notes and semi-structured interviews for determinants of CQI implementation and 'normalisation' using Normalisation Process Theory (NPT) and Tailored Implementation of Chronic Diseases (TICD) frameworks. Results: All interviewed health workers found the CQI mentors and methodology helpful for quality improvement. Total administered 'dose' was higher than planned but 'reach' was limited by resource constraints, particularly staffing shortages. Simple workable improvements to identified root causes were implemented, such as a patient tracking notebook and results filing system. VL monitoring improved over time, but not repeat HIV testing. Besides resource constraints, gaps in knowledge of guidelines, lack of leadership, poor clinical documentation, and data quality gaps reduced CQI implementation fidelity and normalisation. Conclusion: While CQI holds promise, we identified several health system challenges. Priorities for policy makers include improving staffing and strategies to improve clinical documentation. Additional support with implementing clinical guidelines and improving routine data quality are needed. Normalising CQI may be challenging without concurrent health system improvements. [ABSTRACT FROM AUTHOR]

Background South Africa implemented universal test and treat (UTT) in September 2016 in an effort to encourage earlier initiation of antiretroviral therapy (ART). Methods We therefore conducted an interrupted time series (ITS) analysis to assess the impact of UTT on mean CD4 count at ART initiation among adults aged ≥16 years attending 17 public sector primary care clinics in rural South Africa, between July 2014 and March 2019. Results Among 20 599 individuals (69% women), CD4 counts were available for 74%. Mean CD4 at ART initiation increased from 317.1 cells/μL (95% confidence interval [CI], 308.6 to 325.6) 1 to 8 months prior to UTT to 421.0 cells/μL (95% CI, 413.0 to 429.0) 1 to 12 months after UTT, including an immediate increase of 124.2 cells/μL (95% CI, 102.2 to 146.1). However, mean CD4 count subsequently fell to 389.5 cells/μL (95% CI, 381.8 to 397.1) 13 to 30 months after UTT but remained above pre-UTT levels. Men initiated ART at lower CD4 counts than women (–118.2 cells/μL, 95% CI, –125.5 to –111.0) throughout the study. Conclusions Although UTT led to an immediate increase in CD4 count at ART initiation in this rural community, the long-term effects were modest. More efforts are needed to increase initiation of ART early in those living with human immunodeficiency virus, particularly men. [ABSTRACT FROM AUTHOR]

Introduction: The World Health Organization recommends lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women living with HIV. Effective transitioning from maternal and child health to ART services, and long- term retention in ART care postpartum is crucial to the successful implementation of lifelong ART for pregnant women. This systematic review aims to determine which interventions improve (1) retention within prevention of mother-to-child HIV transmission (PMTCT) programmes after birth, (2) transitioning from PMTCT to general ART programmes in the postpartum period, and (3) retention of postpartum women in general ART programmes. Methods: We searched Medline, Embase, ISI Web of Knowledge, the regional World Health Organization databases and conference abstracts for data published between 2002 and 2015. The quality of all included studies was assessed using the GRADE criteria. Results and Discussion: After screening 8324 records, we identified ten studies for inclusion in this review, all of which were from sub-Saharan Africa except for one from the United Kingdom. Two randomized trials found that phone calls and/or text messages improved early (six to ten weeks) postpartum retention in PMTCT. One cluster-randomized trial and three cohort studies found an inconsistent impact of different levels of integration between antenatal care/PMTCT and ART care on postpartum retention. The inconsistent results of the four identified studies on care integration are likely due to low study quality, and heterogeneity in intervention design and outcome measures. Several randomized trials on postpartum retention in HIV care are currently under way. Conclusions: Overall, the evidence base for interventions to improve postpartum retention in HIVcare is weak. Nevertheless, there is some evidence that phone-based interventions can improve retention in PMTCT in the first one to three months postpartum. Keywords: PMTCT; retention; Option B +; postpartum; HIV; antiretroviral therapy; loss to follow-up., Introduction The human immunodeficiency virus (HIV) can be transmitted from the mother to her child during pregnancy and birth through blood, or postnatally through breast milk. With mounting evidence from [...]

Since the advent of combination antiretroviral therapy to successfully treat HIV infection, drug--drug interactions (DDIs) have become a significant problem as many antiretrovirals (ARVs) are metabolized in the liver. Antituberculous therapy traditionally includes rifamycins, particularly rifampicin. Rifabutin (RBT) has shown similar efficacy as rifampicin but induces CYP3A4 to a lesser degree and is less likely to have DDIs with ARVs. We identified 14 DDI pharmacokinetic studies on HIV monoinfected and HIV-tuberculosis coinfected individuals, and the remaining studies were healthy volunteer studies. Although RBT may be coadministered with most nonnucleoside reverse transcriptase inhibitors, identifying the optimal dose with ritonavir-boosted or cobicistat-boosted protease inhibitors is challenging because of concern about adverse effects with increased RBT exposure. Limited healthy volunteer studies on other ARV drug classes and RBT suggest that dose modification may be unnecessary. The paucity of data assessing clinical tuberculosis endpoints concurrently with RBT and ARV pharmacokinetics limits evidence-based recommendations on the optimal dose of RBT within available ARV drug classes. [ABSTRACT FROM AUTHOR]

Since the advent of combination antiretroviral therapy to successfully treat HIV infection, drug-drug interactions (DDIs) have become a significant problem as many antiretrovirals (ARVs) are metabolized in the liver. Antituberculous therapy traditionally includes rifamycins, particularly rifampicin. Rifabutin (RBT) has shown similar efficacy as rifampicin but induces CYP3A4 to a lesser degree and is less likely to have DDIs with ARVs. We identified 14 DDI pharmacokinetic studies on HIV monoinfected and HIV-tuberculosis coinfected individuals, and the remaining studies were healthy volunteer studies. Although RBT may be coadministered with most nonnucleoside reverse transcriptase inhibitors, identifying the optimal dose with ritonavir-boosted or cobicistat-boosted protease inhibitors is challenging because of concern about adverse effects with increased RBT exposure. Limited healthy volunteer studies on other ARV drug classes and RBT suggest that dose modification may be unnecessary. The paucity of data assessing clinical tuberculosis endpoints concurrently with RBT and ARV pharmacokinetics limits evidence-based recommendations on the optimal dose of RBT within available ARV drug classes.