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In a randomised trial, we found that integrated maternal HIV and infant health services through the end of breastfeeding were significantly associated with the primary outcome of engagement in HIV care and viral suppression at 12 months postpartum, compared to the standard of care. Here, we quantitatively explore potential psychosocial modifiers and mediators of this association. Our findings suggest that the intervention was significantly more effective among women experiencing an unintended pregnancy but did not improve outcomes among women reporting risky alcohol use. Although not statistically significant, our results suggest that the intervention may also be more effective among women experiencing higher levels of poverty and HIV-related stigma. We observed no definitive mediator of the intervention effect, but women allocated to integrated services reported better relationships with their healthcare providers through 12 months postpartum. These findings point to high-risk groups that may benefit the most from integrated care, as well as groups for whom these benefits are hampered and that warrant further attention in intervention development and evaluation., (© 2023. The Author(s).)

Rationale: Adherence to antiretroviral therapy (ART) is a global concern among pregnant and postpartum women living with HIV (WLHIV). Research focusing on peripartum WLHIV and how they balance adherence, engaging in HIV care, and other forms of self-care is limited. Women's empowerment theories have been applied to myriad health behaviors to understand patterns, establish mechanisms, and develop interventions; yet empowerment theory as applied to ART is under-researched., Objective: Seeking deeper insight into peripartum health behaviors, we examine these factors using Naila Kabeer's (1999) women's empowerment theory, which denotes resources, agency, and achievements as three primary and interrelated components of empowerment., Methods: Data were collected in Gugulethu, South Africa, between March and July 2018. Thirty in-depth interviews were conducted with WLHIV at 32-35 weeks of pregnancy, with topics including experiences related to ART adherence and meanings of empowerment in motherhood. Analyses had two phases: (1) inductive open-coding for emergent themes; and (2) classifying themes into Kabeer's empowerment theory., Results: Participants expressed that resources play a critical role in adherence, ranging from practical support to motivational support provided by both family and partners. Agency is experienced as a desire to be an independent mother in the often-expected event that partners withdraw support. Participants described achievements as time-oriented goals, ranging from having a baby born without HIV to living a long and productive life., Conclusions: These findings suggest that a promising and innovative approach to improving ART adherence across the peripartum transition would focus on understanding resources as an enabling environment, build on existing feelings of agency, and highlight the lifelong goals achievable with high levels of adherence. A better understanding of how women's empowerment evolves over the course of pregnancy and into the postpartum period will support intervention development aimed at improving ART adherence and potentially additional peripartum health behaviors., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Introduction: Retaining postpartum women living with HIV in ongoing care is critical for the health of the mother-child dyad but low adherence to antiretroviral therapy (ART) and retention in HIV care are a global concern. This issue is particularly salient in South Africa, where approximately 50% of women fall out of the care cascade by 6 months postpartum. The purpose of this secondary analysis is to understand the strategies that women use to navigate HIV care during the postpartum period., Methods: This study was conducted in Gugulethu, in Cape Town, South Africa. In-depth interviews were conducted with 21 study participants at 18-months postpartum. Participants were interviewed about their perceptions and experiences of their postpartum HIV care, and barriers and facilitators to their adherence and retention., Results: All participants reported using care navigation strategies across a spectrum of individual, interpersonal and structural levels to remain retained in care and adherent to ART. Participants expressed the importance of individual empowerment and knowledge of treatment benefits for their HIV care. Interpersonal relationships were discussed as a pathway to access both psychosocial and tangible support. Participants described overcoming structural barriers to care through creative problem solving and identified opportunities for care delivery improvement., Discussion: Participants described a wide range of overlapping and interconnected care navigation strategies. Consistent with the assets model, participants discussed their own capacity and that of their communities to engage in lifelong HIV care. Better understanding of potentially successful individual care navigation strategies should guide future intervention work., Trial Registration: ClinicalTrials.gov NCT01933477.

Background: With an increasing number of countries implementing Option B+ guidelines of lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women, there is urgent need to identify effective approaches for retaining this growing and highly vulnerable population in ART care., Methods: Newly postpartum, breastfeeding women who initiated ART in pregnancy and met eligibility criteria were enrolled, and offered the choice of two options for postpartum ART care: (i) referral to existing network of community-based adherence clubs or (ii) referral to local primary health care clinic (PHC). Women were followed at study measurement visits conducted separately from either service. Primary outcome was a composite endpoint of retention in ART services and viral suppression [VS < 50 copies/mL based on viral load (VL) testing at measurement visits] at 12 months postpartum. Outcomes were compared across postpartum services using chi-square, Fisher's exact tests and Poisson regression models. The primary outcome was compared across services where women were receiving care at 12 months postpartum in exploratory analyses., Results: Between February and September 2015, 129 women (median age: 28.9 years; median time postpartum: 10 days) were enrolled with 65% opting to receive postpartum HIV care through an adherence club. Among 110 women retained at study measurement visits, 91 (83%) achieved the composite endpoint, with no difference between those who originally chose clubs versus those who chose PHC services. Movement from an adherence club to PHC services was common: 31% of women who originally chose clubs and were engaged in care at 12 months postpartum were attending a PHC service. Further, levels of VS differed significantly by where women were accessing ART care at 12 months postpartum, regardless of initial choice: 98% of women receiving care in an adherence club and 76% receiving care at PHC had VS < 50 copies/mL at 12 months postpartum (p = 0.001)., Conclusion: This study found comparable outcomes related to retention and VS at 12 months postpartum between women choosing adherence clubs and those choosing PHC. However, movement between postpartum services among those who originally chose adherence clubs was common, with poorer VS outcomes among women leaving clubs and returning to PHC services., Trial Registration: ClinicalTrials.gov NCT02417675 , April 16, 2015 (retrospectively registered).

Postpartum HIV care retention rates are well below retention rates of the general adult population. The Maternal-Child Health Antiretroviral Therapy (MCH-ART) trial tested the benefit of integrating postpartum maternal ART and pediatric care through the end of breastfeeding compared to the standard of care of immediate postpartum referral of mother and infant to separate services. After the trial, twenty-one participants completed in-depth interviews to understand the acceptability of the service integration and the potentially differing "lived" experiences of the women randomized to the two conditions. Key findings include: (1) the MCH-ART integrated service was found to be acceptable, (2) women in the intervention condition expressed more negative feelings around the need to be transferred to general ART services and (3) women in the intervention condition perceived that they had more influence in selecting the clinic to which they would be transferred compared to those in the control group, although there was no actual difference by study design. Future work should more directly evaluate the impact of shared decision-making and long-term relationships with clinic staff on patient engagement and retention in HIV care.

Objectives: Measuring retention is critical for antiretroviral therapy (ART) management and program monitoring; however, many definitions and data sources, usually from single health facilities, are used. We used routine electronic data, linked across facilities, to examine the impact of definitions and data sources on retention estimates among women in Cape Town, South Africa., Design: Retrospective cohort study., Methods: We compiled routine electronic laboratory, pharmacy and clinic visit data for 617 women who started ART during pregnancy (2013-2014) and estimated 24-month retention using different definitions and data sources. We used logistic regression to assess consistency of associations between risk factors and retention, and receiver operating characteristics analyses to describe how different retention estimates predict viremia at 12 months on ART., Results: Using all available data sources, retention ranged from 41% (no gap >180 days) to 72% (100% 12-month visit constancy). Laboratory data (expected infrequently) underestimated retention compared with clinic visit data that identified more than 80% of women considered retained in all definitions. In all estimates, associations with known risk factors for nonretention remained consistent and retention declined over time: 77, 65 and 58% retained using all data sources in months 6-12, 12-18 and 18-24, respectively (P < 0.001). The 180-day gap definition was most strongly associated with viremia (odds ratio 24.3 95% confidence interval 12.0-48.9, all data sources)., Conclusion: Researchers must carefully consider the most appropriate retention definition and data source depending on available data. Presenting more than one approach may be warranted to obtain estimates that are context-appropriate and comparable across settings.

Background: Integrated maternal and child health (MCH) services improve women's postpartum antiretroviral therapy (ART) outcomes during breastfeeding; however, long-term outcomes after transfer to general ART services remain unknown., Methods: The MCH-ART trial demonstrated that maternal retention and viral suppression at 12-months postpartum were improved significantly among women randomized to integrated MCH services continued in the antenatal clinic through cessation of breastfeeding (MCH-ART arm) compared with immediate transfer to general ART services postpartum (standard of care). We reviewed electronic health records for all women who participated in the MCH-ART trial to ascertain retention and gaps in care and invited all women for a study visit 36- to 60-months postpartum including viral load testing., Results: Of 471 women in MCH-ART, 450 (96%) contributed electronic health record data and 353 (75%) completed the study visit (median 44-month postpartum). At this time, outcomes were identical in both trial arms: 67% retained in care (P = 0.994) and 56% with viral loads <50 copies/mL (P = 0.751). Experiencing a gap in care after delivery was delayed in the MCH-ART arm with 17%, 36%, and 45% of women experienced a gap in care by 12-, 24-, and 36-months postpartum compared with 35%, 48%, and 57% in the standard of care arm, respectively., Conclusions: The benefits of integrated maternal HIV and child health care did not persist after transfer to general ART services. The transfer of women postpartum to routine adult care is a critical period requiring interventions to support continuity of HIV care.

Background: HIV-status disclosure is widely encouraged by counseling services, in part because it is thought to improve antiretroviral therapy (ART) adherence and thus HIV viral suppression. However, few longitudinal studies have examined the impact of disclosure on HIV viral load (VL) during pregnancy and postpartum., Methods: We explored these associations among 1187 women living with HIV, enrolled between March 2013 and June 2014 in Cape Town, South Africa., Results: Among women who tested HIV-positive before pregnancy, we observed no association between disclosure and VL at entry into antenatal care among those already on ART, nor at delivery and 12 months postpartum among those initiating ART. Among women who tested HIV-positive during pregnancy and initiated ART subsequently, disclosure to a male partner was associated with a reduced risk of VL ≥50 copies/mL at delivery (adjusted risk ratio: 0.56; 95% confidence interval: 0.31 to 1.01). After stratification by relationship status, this association was only observed among women who were married and/or cohabiting. In addition, disclosure to ≥1 family/community member was associated with a reduced risk of VL ≥50 copies/mL at 12 months postpartum (adjusted risk ratio: 0.69; 95% confidence interval: 0.48 to 0.97) among newly-diagnosed women., Conclusions: These findings suggest that the impact of disclosure on VL is modified by 3 factors: (1) timing of HIV diagnosis (before vs. during the pregnancy); (2) relationship to the person(s) to whom women disclose; and (3) in the case of disclosure to a male partner, relationship status. Counseling about disclosure may be most effective if tailored to individual women's circumstances.

Background: The impact of HIV and antiretrovirals (ART) on long-term mental health in perinatally infected children has not been well studied in sub-Saharan Africa where HIV is most prevalent., Setting: Cape Town, South Africa., Methods: We investigated mental health measures, including depression, anxiety, attention-deficit hyperactivity disorder, motivation, disruptive behavior, and functioning in perinatally infected adolescents (PHIV+) stable on ART within the Cape Town Adolescent Antiretroviral Cohort. Two hundred four adolescents living with HIV (median age 10 years; mean CD4 953) and a sample of 44 uninfected adolescents were enrolled. The Beck Youth Inventories, Children's Motivation Scale, Conner's Parent's Rating Scale, and Child Behavior Checklist were administered. Among PHIV+, we explored independent associations between HIV-related stigma, recent life stressors, sociodemographic, clinical, and caregiver-related variables, and mental health measures., Results: PHIV+ had poorer functional competence, self-concept and motivation, higher levels of disruptive behavior, depression and attention-deficit hyperactivity disorder symptoms and clinically significant anger and disruptive behavior. Within the PHIV+ group, the loss of both biological parents was associated with higher levels of disruptive behavior. Within the PHIV+, factors associated with mental health symptoms and poorer functioning were mostly sociodemographic factors, HIV-related stigma, and life stressors. Age of initiation of ART was associated with self-concept, and failing first-line ART with internalizing and externalizing behavior problems., Conclusions: PHIV+ are likely to face future physical and psychological health consequences related to the functional competence challenges they face if mental health care is not made a priority in the fight against HIV.

Objective: Unintended pregnancies are common among women living with HIV, but there are no data on their long-term impact on treatment outcomes. In a cohort of women initiating antiretroviral therapy (ART) during pregnancy, we examined the association between the intendedness of the current pregnancy, measured antenatally, and elevated viral load up to 5 years postpartum., Design: Prospective study with enrolment at entry into antenatal care and follow-up at study visits separate from routine care., Methods: At enrolment women completed the London Measure of Unplanned Pregnancy. Mixed effects models examined the impact of the intendedness of the pregnancy (planned versus each of unplanned or ambivalent, respectively) on viral load 50 or more copies/ml across postpartum study visits., Results: Overall, 459 women were followed for a median of 43 months postpartum, contributing 2535 viral load measures (median per woman: 6). Ambivalent and unplanned pregnancy were commonly reported (20 and 60%, respectively), and the proportion of women with elevated viral load increased over time (16% at 6 weeks to 43% by 36-60 months postpartum). Compared with those reporting a planned pregnancy, elevated viral load was more common among women reporting an unplanned pregnancy (odds ratio: 2.87; 95% confidence interval: 1.46-5.64), with a trend towards a higher odds among those reporting ambivalence (odds ratio: 2.19; 95% confidence interval: 0.97-4.82); associations persisted after adjustment for a wide range of demographic, clinical and psychosocial factors., Conclusion: These novel data suggest that unplanned pregnancy may be a prevalent and persistent predictor of poor ART outcomes among women initiating ART during pregnancy.

Introduction: Routine HIV viral load (VL) monitoring is recommended for patients on antiretroviral therapy, but frequent VL testing, required in pregnant and postpartum women, is often not feasible. Self-reported adherence can be valuable, but little is known about its longitudinal characteristics., Methods: We followed women living with HIV from antiretroviral therapy initiation in pregnancy through 18-month postpartum in Cape Town, South Africa, with repeated measurement of VL and self-reported adherence using a 3-item scale. We used generalized estimating equations [with results presented as odds ratios (ORs) with 95% confidence intervals (CIs)] to investigate the association between viremia and change in adherence over pairs of consecutive visits., Results: Among 2085 visit pairs from 433 women, a decrease in self-reported adherence relative to the previous visit on any of the 3 self-report items, or the combined scale, was associated with VL >50 and >1000 copies per milliliter. The best-performing thresholds to predict VL >50 copies per milliliter were a single-level decrease on the Likert response item "how good a job did you do at taking your HIV medicines in the way that you were supposed to?" (OR 2.08, 95% CI: 1.48 to 2.91), and a decrease equivalent to ≥5 missed doses or a one-level decrease in score on either of 2 Likert items (OR 1.34, 95% CI: 1.06 to 1.69)., Conclusions: Longitudinal changes in self-reported adherence can help identify patients with viremia. This approach warrants consideration in settings where frequent VL monitoring or other objective adherence measures are not possible.

Across sub-Saharan Africa, prevention of mother-to-child transmission services are encountering increasing numbers of women already established on antiretroviral therapy (ART) when entering antenatal care. However, there are few data examining ART adherence and HIV viral load in this group. We used multivariable logistic regression models to examine self-reported suboptimal adherence (defined as missed ART doses on ≥2 days during the preceding 30 days), elevated viral load (≥1000 copies/mL), and factors associated with each among women entering antenatal care on ART. Participants were recruited from one primary care clinic in Gugulethu, Cape Town, as part of a larger study of HIV-positive pregnant and postpartum women. Among 482 pregnant women established on ART and enrolled between May 2013 and June 2014 (median age: 31 years; median duration of ART use: 3 years), 15% reported suboptimal adherence and 12% had elevated viral load. After adjustment for age, suboptimal adherence was significantly more common among women who were not married/cohabiting and women who reported a higher level of concern about taking ART; a higher level of adherence self-efficacy was associated with a reduced odds of suboptimal adherence. In a multivariable model, elevated viral load was significantly associated with previous discontinuation of ART, a higher level of concern about taking ART, and report of an unintended pregnancy. Suboptimal adherence and elevated viral load are common among women entering antenatal care already on ART. Our findings highlight specific beliefs and concerns about ART use during pregnancy that should be addressed in counselling messaging, and suggest that family planning should be more effectively integrated into HIV care. Including adherence and viral load monitoring as part of pregnancy planning for women on ART may be important to achieve safer conception and promote healthy pregnancies.

Introduction: Many prevention of mother-to-child HIV transmission programmes across Africa initiate HIV-infected (HIV positive) pregnant women on lifelong antiretroviral therapy (ART) on the first day of antenatal care ("same-day" initiation). However, there are concerns that same-day initiation may limit patient preparation before starting ART and contribute to subsequent non-adherence, disengagement from care and raised viral load. We examined if same-day initiation was associated with viral suppression and engagement in care during pregnancy., Methods: Consecutive ART-eligible pregnant women making their first antenatal care (ANC) visit at a primary care facility in Cape Town, South Africa were enrolled into a prospective cohort between March 2013 and June 2014. Before July 2013, ART eligibility was based on CD4 cell count ≤350 cells/μL ("Option A"), with a 1 to 2 week delay from the first ANC visit to ART initiation for patient preparation; thereafter all women were eligible regardless of CD4 cell count ("Option B+") and offered ART on the same day as first ANC visit. Women were followed with viral load testing conducted separately from routine ART services, and engagement in ART services was measured using routinely collected clinic, pharmacy and laboratory records through 12 months postpartum., Results: Among 628 HIV-positive women (median age, 28 years; median gestation at ART start, 21 weeks; 55% newly diagnosed with HIV), 73% initiated ART same-day; this proportion was higher under Option B+ versus Option A (85% vs. 20%). Levels of viral suppression (viral load <50 copies/mL) at delivery (74% vs. 82%) and 12 months postpartum (74% vs. 71%) were similar under same-day versus delayed initiation respectively. Findings were consistent when viral suppression was defined at <1000 copies/mL, after adjustment for demographic/clinical measures and across subgroups of age, CD4 and timing of HIV diagnosis. Time to first viral rebound following initial suppression did not differ by timing of ART initiation nor did engagement in care through 12 months postpartum (same-day = 73%, delayed = 73%, p = 0.910)., Conclusions: These data suggest that same-day ART initiation during pregnancy is not associated with lower levels of engagement in care or viral suppression through 12 months post-delivery in this setting, providing reassurance to ART programmes implementing Option B+., (© 2018 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.)

Background: The numbers of women initiating lifelong antiretroviral therapy (ART) during pregnancy and postpartum is increasing rapidly, presenting a burden on health systems and an urgent need for scalable models of care for this population. In a pilot project, we referred postpartum women who initiated ART during pregnancy to a community-based model of differentiated ART services., Methods: Eligible women (on ART for at least 3 months with viral load (VL)<1000 copies/mL) were offered a choice of two ART models of care: (i) referral to an existing system of community-based 'adherence clubs', operated by lay counsellors with medication collection every 2-4 months; or (ii) referral to local primary healthcare clinics (PHC) with services provided by clinicians and medication collection every 1-2 months (local standard of care for postpartum ART). For evaluation, women were followed through 6-months postpartum with VL testing separate from either ART service., Results: Through September 2015, n  = 129 women were enrolled (median age, 28 years; median time postpartum, 10 days). Overall, 65% ( n  = 84) chose adherence clubs and 35% ( n  = 45) chose PHCs; there were no demographic or clinical predictors of this choice. Location of service delivery was commonly cited as a reason for choice by women selecting either model of care; shorter waiting times, ability to receive ART from lay counsellors and less frequent appointments were motivations for choosing adherence clubs. Among women choosing adherence clubs, 15% never attended the service and another 11% attended the service but were not retained through six months postpartum. Overall, 86% of women ( n  = 111) remained in the evaluation through 6 months postpartum; in this group, there were no differences in VL<1000 copies/mL at six months postpartum between women choosing PHCs (88%) vs. adherence clubs (92%; p  = 0.483), but women who were not retained in adherence clubs were more likely to have VL≥1000 copies/mL compared to those who remained ( p  = 0.002)., Discussion: Adherence clubs may be a valuable model for postpartum women initiating ART in pregnancy, with good short-term outcomes observed during this critical period. To support optimal implementation, further research is needed into patient preferences for models of care, with consideration of integration of maternal and child health services, while ART adherence and retention require ongoing consideration in this population., Competing Interests: None of the authors have any competing interests to declare.

Maternal adherence to antiretroviral therapy (ART) is a concern and monitoring adherence presents a significant challenge in low-resource settings. We investigated the association between self-reported adherence, measured using a simple three-item scale, and elevated viral load (VL) among HIV-infected pregnant and postpartum women on ART in Cape Town, South Africa. This is the first reported use of this scale in a non-English speaking setting and it achieved good psychometric characteristics (Cronbach α = 0.79). Among 452 women included in the analysis, only 12 % reported perfect adherence on the self-report scale, while 92 % had a VL <1000 copies/mL. Having a raised VL was consistently associated with lower median adherence scores and the area under the curve for the scale was 0.599, 0.656 and 0.642 using a VL cut-off of ≥50, ≥1000 and ≥10000 copies/mL, respectively. This simple self-report adherence scale shows potential as a first-stage adherence screener in this setting. Maternal adherence monitoring in low resource settings requires attention in the era of universal ART, and the value of this simple adherence scale in routine ART care settings warrants further investigation.

Objective: Tenofovir (TDF) affects bone health and is widely used in pregnancy but data are limited on the effects of TDF exposure in utero. We examined the association between duration of in-utero TDF exposure and linear growth in HIV-exposed, uninfected (HEU) infants., Design: A prospective cohort of pregnant women initiating TDF-containing regimens at primary care services in Cape Town, South Africa, were enrolled and followed with their breastfeeding infants through 12 months postpartum., Methods: Length-for-age z scores (LAZ) were calculated from infant lengths reported at birth and measured at 6, 12, 24, 36 and 48 weeks, using Fenton and WHO standards. Linear mixed-effects models were used to examine the association between duration of TDF exposure and LAZ over time., Results: In 464 singleton mother-infant pairs (median CD4 at ART initiation, 346 cells/μl; viral load (VL), 4.0 log10 copies/ml), the median duration of in-utero TDF exposure was 16.7 weeks (interquartile range, IQR 11.0-22.0) with 31, 44 and 25% of infants exposed to less than 12, 12-22 and more than 22 weeks of TDF, respectively. Overall, 12% of children were stunted (LAZ < -2) at 48 weeks. Duration of exposure was not associated with LAZ: adjusted mean difference for more than 22 vs less than 12 weeks, -0.12 (95% CI -0.47 to 0.23); 12-22 vs less than 12 weeks, -0.06 (95% CI -0.35 to 0.24). Mean LAZ was 0.15 lower per log increase in maternal VL at ART initiation (95% CI -0.29 to -0.0001)., Conclusion: These data suggest no association between duration of TDF exposure in utero and early linear growth.

Background: Prevention of mother-to-child transmission of HIV implementation faces significant challenges globally, particularly in the context of universal lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women., Methods: We describe the rationale and methods of the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) study, an implementation science project examining strategies for providing HIV care and treatment to HIV-infected women who initiate ART during pregnancy and their HIV-exposed infants., Results: MCH-ART is composed of 3 interrelated study designs across the antenatal and postnatal periods. Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women seeking antenatal care; phase 2 is an observational cohort of all women from phase 1 who are eligible for initiation of ART following local guidelines; and phase 3 is a randomized trial of strategies for delivering ART to breastfeeding women from phase 2 during the postpartum period. During each phase, a set of study measurement visits is carried out separately from antenatal care and ART services; a maximum of 9 visits takes place from the beginning of antenatal care through 12 months postpartum. In parallel, in-depth interviews are used to examine issues of ART adherence and retention qualitatively, and costs and cost-effectiveness of models of care are examined. Separate substudies examine health outcomes in HIV-uninfected women and their HIV-unexposed infants, and the role of the adherence club model for long-term adherence and retention., Discussion: Combining observational and experimental components, the MCH-ART study presents a novel approach to understand and optimize ART delivery for MCH., Competing Interests: The authors have no conflicts of interest to disclose.