Why do Integrated Maternal HIV and Infant Healthcare Services work? A Secondary Analysis of a Randomised Controlled Trial in South Africa.

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.

Mental health and ART adherence among adolescents living with HIV in Mozambique.

Little is known about the mental health needs of adolescents living with HIV (ALWH) in Mozambique, including the potential relationship between mental health challenges and poor antiretroviral treatment (ART) adherence. We examined mental health problems (anxiety, depression, post-traumatic stress disorder [PTSD] symptoms and impairment) and their association with self-reported ART adherence among ALWH ages 15-19 in Nampula, Mozambique. The associations between each mental health problem area and sub-optimal adherence were estimated using logistic regression, controlling for age, education, and social support, with interaction by gender. Males had significantly higher anxiety (5.6 vs 4.3, p = 0.01), depression (5.8 vs 4.1, p = 0.005), and PTSD (13.3 vs 9.8, p = 0.02) symptoms and impairment (1.8 vs 0.56, p<0.0001) scores than females. Proportion reporting sub-optimal adherence (65%) did not differ by gender. Higher anxiety, depression, and PTSD symptom and impairment scores were significantly associated with higher odds of sub-optimal ART adherence in males but not females. Among Mozambican ALWH, mental health problems were prevalent and two-thirds had ART adherence less than 90%. Worse mental health was associated with increased odds of sub-optimal ART adherence in males but not females. Interventions are needed to address mental health problems and improve ART adherence in Mozambican ALWH, particularly among males.

Positive attitudes toward adoption of a multi-component intervention strategy aimed at improving HIV outcomes among adolescents and young people in Nampula, Mozambique: perspectives of HIV care providers.

BACKGROUND: Service providers' attitudes toward interventions are essential for adopting and implementing novel interventions into healthcare settings, but evidence of evaluations in the HIV context is still limited. This study is part of the CombinADO cluster randomized trial (ClinicalTrials.gov NCT04930367), which is investigating the effectiveness of a multi-component intervention package (CombinADO strategy) aimed at improving HIV outcomes among adolescents and young adults living with HIV (AYAHIV) in Mozambique. In this paper we present findings on key stakeholder attitudes toward adopting study interventions into local health services. METHODS: Between September and December 2021, we conducted a cross-sectional survey with a purposive sample of 59 key stakeholders providing and overseeing HIV care among AYAHIV in 12 health facilities participating in the CombinADO trial, who completed a 9-item scale on attitudes towards adopting the trial intervention packages in health facilities. Data were collected in the pre-implementation phase of the study and included individual stakeholder and facility-level characteristics. We used generalized linear regression to examine the associations of stakeholder attitude scores with stakeholder and facility-level characteristics. RESULTS: Overall, service-providing stakeholders within this setting reported positive attitudes regarding adopting intervention packages across study clinic sites; the overall mean total attitude score was 35.0 ([SD] = 2.59, Range = [30-41]). The study package assessed (control or intervention condition) and the number of healthcare workers delivering ART care in participating clinics were the only significant explanatory variables to predict higher attitude scores among stakeholders (ß = 1.57, 95% CI = 0.34-2.80, p = 0.01 and ß = 1.57, 95% CI = 0.06-3.08, p = 0.04 respectively). CONCLUSIONS: This study found positive attitudes toward adopting the multi-component CombinADO study interventions among HIV care providers for AYAHIV in Nampula, Mozambique. Our findings suggest that adequate training and human resource availability may be important in promoting the adoption of novel multi-component interventions in healthcare services by influencing healthcare provider attitudes.

Relationship between pre-pregnancy maternal body mass index and infant weight trajectories in HIV-exposed and HIV-unexposed infants.

BACKGROUND: Maternal HIV and antiretroviral therapy (ART) exposure in utero may influence infant weight, but the contribution of maternal y body mass index (BMI) to early life overweight and obesity is not clear. OBJECTIVE: To estimate associations between maternal BMI at entry to antenatal care (ANC) and infant weight through approximately 1 year of age and to evaluate whether associations were modified by maternal HIV status, maternal HIV and viral load, breastfeeding intensity through 6 months or timing of entry into ANC. METHODS: We followed HIV-uninfected and -infected pregnant women initiating efavirenz-based ART from first antenatal visit through 12 months postpartum. Infant weight was assessed via World Health Organization BMI and weight-for-length z-scores (WLZ) at 6 weeks, 3, 6, 9 and 12 months. We used multivariable linear mixed-effects models to estimate associations between maternal BMI and infant z-scores over time. RESULTS: In 861 HIV-uninfected infants (454 HIV-exposed; 407 HIV-unexposed), nearly 20% of infants were overweight or obese by 12 months of age, regardless of HIV exposure status. In multivariable analyses, increasing maternal BMI category was positively associated with higher infant BMIZ and WLZ scores between 6 weeks and 12 months of age and did not differ by HIV exposure status. However, HIV-exposed infants had slightly lower BMIZ and WLZ trajectories through 12 months of age, compared with HIV-unexposed infants across all maternal BMI categories. Differences in BMIZ and WLZ scores by HIV exposure were not explained by timing of entry into ANC or maternal viral load pre-ART initiation, but z-scores were slightly higher for HIV-exposed infants who were predominantly or exclusively versus partially breastfed. CONCLUSIONS: These findings suggest maternal BMI influences early infant weight gain, regardless of infant HIV exposure status. Intervention to reduce maternal BMI may help to address growing concerns about obesity among HIV-uninfected children.

Alcohol use and intimate partner violence in HIV-uninfected pregnant women in Cape Town, South Africa.

In settings with a high burden of HIV, pregnant women often experience a cluster of risk factors, including alcohol use and intimate partner violence (IPV). These interrelated risks are poorly understood among pregnant women at risk of HIV in sub-Saharan Africa. We aim to determine cross-sectional associations between pregnant women's alcohol use and victimization due to IPV in the HIV-Unexposed-Uninfected Mother-Infant Cohort Study in Cape Town, South Africa. Women who tested HIV-negative at first antenatal care (ANC) visit were followed to delivery. Trained interviewers collected demographic and psychosocial information, including recent alcohol use and experiences of IPV victimization. We assess the prevalence of alcohol use and associations with IPV using multivariable logistic regression. In 406 HIV-uninfected pregnant women (mean age = 28 years; mean gestational age = 21 weeks), 41 (10%) reported alcohol consumption in the past 12 months; 30/41 (73%) of these at hazardous levels. Any and hazardous alcohol use were associated with greater odds of reporting past year IPV (adjusted odds ratio [aOR] for hazardous use: 3.24, 95% CI = 1.11, 7.56; aOR for any alcohol use: 2.97, 95% CI = 1.19, 7.45). These data suggest the occurrence of overlapping HIV risk factors among pregnant women and may help design improved health interventions in this population.

Mother-child separation among women living with HIV and their children in the first four years postpartum in South Africa.

OBJECTIVES: Mother-child pairs may separate during early life, yet the health impacts thereof are unclear. We explored the patterns and impact of separation among women living with HIV (WLHIV) and their children in South Africa. METHODS: WLHIV who had initiated antiretroviral therapy (ART) during pregnancy received HIV viral load (VL) testing and completed a timeline questionnaire of mother-child separation since delivery at 3-5 years post-partum. Health care usage was abstracted from routine medical records. We examined associations between separation and (a) maternal health outcomes (engagement in HIV care and HIV viral suppression, [VS]) and (b) child health outcomes (post-breastfeeding HIV testing and immunisation completion), using logistic regression. RESULTS: Of 346 mother-child pairs (median maternal age at antenatal ART initiation, 28 years), 24% were ever separated (median time to first separation 20 months, interquartile range [IQR] 9, 31). Most separated children were living with their grandmothers (65/83, 78%). Mothers who ever separated were younger, and more likely to be employed, and to reside in informal housing than those who never separated. Any separation reduced the odds of VS ≤ 50 copies/mL at four years post-partum (odds ratio 0.57; 95% CI 0.34-0.93); associations were similar for VL ≤ 1000 copies/mL and maternal engagement in care. No association was found between separation and child confirmatory HIV testing or immunisation completion. CONCLUSIONS: In this setting, mother-child separation is common in the first four years of life and appears associated with suboptimal maternal outcomes. Further research is required to understand the drivers and implications of mother-child separation.

OBJECTIFS: Les couples mère-enfant peuvent être séparés au début de la vie, mais les effets sur la santé ne sont pas clairs. Nous avons exploré les modèles et l'impact de la séparation chez les femmes vivant avec le VIH (PVVIH) et leurs enfants en Afrique du Sud. MÉTHODES: Les PVVIH qui avaient initié un traitement antirétroviral (ART) pendant la grossesse ont subi un test de charge virale du VIH (CV) et ont rempli un questionnaire chronologique sur la séparation mère-enfant depuis l'accouchement à 3-5 ans post-partum. L'utilisation des soins de santé a été extraite des dossiers médicaux de routine. Nous avons examiné les associations entre la séparation et (a) les résultats pour la santé maternelle (engagement dans les soins du VIH et la suppression virale du VIH [SV]) et (b) les résultats pour la santé de l'enfant (dépistage du VIH après l'allaitement et achèvement de la vaccination), en utilisant la régression logistique. RÉSULTATS: Sur 346 couples mère-enfant (âge maternel médian au début de l'ART prénatal, 28 ans), 24% ont été séparés (délai médian jusqu'à la première séparation 20 mois, intervalle interquartile [IQR] 9 à 31). La plupart des enfants séparés vivaient avec leurs grands-mères (65/83, 78%). Les mères qui ont vécu une telle séparation étaient plus jeunes et plus susceptibles d'avoir un emploi et de vivre dans un logement informel que celles qui ne l'ont jamais vécue. Toute séparation réduisait les chances de SV ≤50 copies/mL à quatre ans après l'accouchement (odds ratio 0,57; IC95%: 0,34-0,93); les associations étaient similaires pour la CV ≤1000 copies/mL et l'engagement de la mère dans les soins. Aucune association n'a été trouvée entre la séparation et le test de confirmation du VIH chez l'enfant ou l'achèvement de la vaccination. CONCLUSIONS: Dans ce contexte, la séparation mère-enfant est courante au cours des quatre premières années de la vie et semble associée à des résultats maternels sous-optimaux. Des recherches supplémentaires sont nécessaires pour comprendre les facteurs et les implications de la séparation mère-enfant.

Life in the Balance: Young Female Sex Workers in Kenya Weigh the Risks of COVID-19 and HIV.

The COVID-19 pandemic has had serious health, economic and psychosocial consequences. Marginalized populations including female sex workers face the stark choice of risking exposure to SARS-CoV-2 as they engage with clients or prioritizing their health at the cost of losing a primary source of income. As part of an ongoing open-label, randomized controlled trial providing daily oral pre-exposure prophylaxis and adherence support, we interviewed 193 of 200 enrolled young female sex workers (18-24 years) in Kisumu, Kenya, about COVID-19 awareness and precautions, access to health services, and sex work during Kenya's pandemic-related lockdown. Nearly all participants were aware of COVID-19 and reported taking protective measures, but only half reported concerns about acquiring SARS-CoV-2. Night curfews and bar closures adversely affected participants' sex work business, reducing the number of clients and payment amounts from clients. Nearly 15% experienced violence from a client or regular, non-paying sex partner during the lockdown period. Participants' access to healthcare services was not disrupted.

RESUMEN: La pandemia de COVID-19 puede tener graves consecuencias sanitarias, económicas y psicosociales. Poblaciones marginadas como las mujeres trabajadoras sexuales se enfrentan a la dura elección de arriesgarse a exponerse al SARS-CoV-2 mientras interactúan con los clientes o priorizar su salud a riesgo de perder su principal fuente de ingresos. Como parte de un ensayo controlado aleatorio abierto en curso que proporcionaba profilaxis pre-exposición (PrEP) oral diaria y apoyo para la adherencia, entrevistamos a 193 de 200 las mujeres trabajadoras sexuales jóvenes (de 18 a 24 años) en Kisumu, Kenia, sobre su conocimiento y precauciones frente al COVID-19, acceso a servicios de salud, y trabajo sexual durante el confinamiento por la pandemia en Kenia. Casi todas las participantes conocían el COVID-19 y reportaron que tomaron medidas de protección, pero sólo la mitad dijeron estar preocupadas por infectarse con el SARS-CoV-2. Los toques de queda nocturnos y los cierres de bares afectaron negativamente al negocio del trabajo sexual, reduciendo el número de clientes y la cantidad que recibieron de los clientes. Casi el 15% experimentó violencia por parte de un cliente o por una pareja sexual habitual que no paga durante el periodo de confinamiento. El acceso de las participantes a los servicios de salud no se vio interrumpido.

The secret life of young adolescents living with HIV in northern Mozambique - a mixed methods study.

BACKGROUND: In Mozambique, HIV infection remains a leading cause of adolescent mortality. With advances in antiretroviral treatment (ART), the population of adolescents living with vertically-acquired HIV is growing. Most studies of adolescents living with HIV (ALHIV) focus on older youth with horizontal infection. As part of a larger study, we examined the characteristics and health care needs of younger ALHIV, including those with vertically-acquired infection to inform preventive interventions. METHODS: We used a convergent mixed-methods design and recruited ALHIV aged 12-14 years who were enrolled in HIV care in three health clinics in Nampula, Mozambique. From 11/2019-3/2020, we conducted 61 quantitative surveys and 14 in-depth interviews with a purposively selected subset of ALHIV who were aware of their HIV status. Descriptive statistical analysis was conducted for quantitative data. Qualitative data were transcribed and analyzed using thematic analysis. RESULTS: The median age of ALHIV was 13 years, 50% were female, 67% lived with ≥1 parent, 70% had lost a parent, 100% were in school; 10% were in a relationship, and 3% had initiated sexual activity. Among 31 ALHIV aware of their serostatus, the median age of antiretroviral treatment (ART) initiation was 8 years (IQR: 6-11); 55% received caregiver support for ART management; 35% reported missing ≥1 ART dose in the last 30 days; 6% had disclosed their HIV-status to friends and 48% reported no one to talk to about HIV-specific issues. Four main themes emerged from the qualitative interviews with ALHIV: a) learning one's HIV-positive status as the beginning of a secret life; b) importance of caregivers' support for ART management; c) high value of ALHIV peer support to overcome isolation, increase HIV literacy, and support adherence; and d) unmet needs for sexual and reproductive health education. CONCLUSION: HIV-related secrecy prevails among ALHIV, a situation exacerbated by caregivers and healthcare providers. Caregivers play a major role in supporting adherence among young ALHIV, yet ALHIV could also benefit from adolescent-friendly services, including peer support, sexual and reproductive health services and preparation for independent health management. Integrating such programs into ART services in Mozambique may be critical to promoting ALHIV health.

Provider- and patient-level costs associated with providing antiretroviral therapy during the postpartum phase to women living with HIV in South Africa: A cost comparison of three postpartum models of care.

OBJECTIVE: To compare the unit and total costs of three models of ART care for mother-infant pairs during the postpartum phase from provider and patient's perspectives: (i) local standard of care with women in general ART services and infants at well-baby clinics; (ii) women and infants continue to receive care through an integrated maternal and child care approach during the postpartum breastfeeding period; and (iii) referral of women directly to community adherence clubs with their infants receiving care at well-baby clinics. METHODS: Capital and recurrent cost data (relating to buildings, furniture, equipment, personnel, overheads, maintenance, medication, diagnostic tests and immunisations) were collected from a provider's perspective at six sites in Cape Town, South Africa. Patient time, collected via time-and-motion observation and questionnaires, was used to estimate patient perspective costs and is comprised of lost productivity time, time spent travelling and the direct cost of travelling. RESULTS: The cost of postpartum ART visits under models I, II and III was US $13, US $10 and US $7 per visit for a mother-infant pair, respectively, in 2018 US$. The annual costs for the mother-infant pair utilising the average visit frequencies (a mean of 4.5, 6.9 and 6.7 visits postpartum for models I, II and III, respectively) including costs for infant immunisations, visits, medication and diagnostic tests for both mothers and infants were: I - US $222, II - US $335 and III - US $249. Sensitivity analysis to assess the impact of visit frequency on visit cost showed that Model I annual costs would be most costly if visit frequency was equalised. CONCLUSION: This comparative analysis of three models of care provides novel data on unit costs and insight into the costs to provide ART and care to mother-infant pairs during the delicate postpartum phase. These costs may be used to help make decisions around integrated services models and differentiated service delivery for postpartum WLH and their children.

OBJECTIF: Comparer le coût et unitaire et total de trois modèles de soins ART pour les paires mère-enfant pendant la phase post-partum selon les perspectives du fournisseur et du patient: (I) - normes locales des soins avec les femmes dans les services généraux de l'ART et les nourrissons dans les cliniques de bien-être pour bébés; (II) - les femmes et les nourrissons continuent de recevoir des soins via une approche intégrée de soins maternels et infantiles pendant la période d'allaitement post-partum; et (III) - orientation des femmes directement vers les clubs d'adhésion communautaires, leurs nourrissons recevant des soins dans les cliniques de bien-être pour bébés pour bébés. MÉTHODES: Les données sur les coûts d'investissement et les coûts récurrents (relatifs aux bâtiments, au mobilier, à l'équipement, au personnel, aux frais généraux, à l'entretien, aux médicaments, aux tests de diagnostic et aux vaccinations) ont été recueillies selon le point de vue du prestataire sur six sites à Cape Town, en Afrique du Sud. Le temps du patient, recueilli via l'observation du temps et des mouvements et des questionnaires, a été utilisé pour estimer les coûts selon le point de vue du patient, et comprend le temps de productivité perdu, le temps passé en déplacement et le coût direct du déplacement. RÉSULTATS: Le coût des visites ART post-partum dans les modèles I, II et III était respectivement de 13 USD, 10 USD et 7 USD par visite pour une paire mère-enfant en USD de 2018. Les coûts annuels pour la paire mère-enfant en utilisant la fréquence moyenne des visites (une moyenne de 4,5 ; 6,9 et 6,7 visites post-partum pour les modèles I, II et III respectivement), y compris les coûts des vaccinations infantiles, des visites, des médicaments et des tests diagnostiques pour les mères et les nourrissons étaient: I - 222 USD, II - 335 USD et III - 249 USD. L'analyse de sensibilité pour évaluer l'impact de la fréquence des visites sur le coût des visites a montré que les coûts annuels du modèle I seraient les plus élevés si la fréquence des visites était égalisée. CONCLUSIONS: Cette analyse comparative de trois modèles de soins fournit de nouvelles données sur les coûts unitaires et un aperçu des coûts de fourniture de l'ART et de soins aux paires mère-enfant pendant la phase délicate du post-partum. Ces coûts peuvent être utilisés pour aider à la prise des décisions concernant les modèles de services intégrés et la prestation de services différenciés pour les femmes en période de post-partum et leurs enfants.

Does HIV infection modify the relationship between pre-pregnancy body mass index and adverse birth outcomes?

BACKGROUND: South Africa faces dual epidemics of HIV and obesity; however, little research has explored whether HIV status influences associations between pre-pregnancy body mass index (BMI) and adverse birth outcomes. OBJECTIVES: To examine associations between pre-pregnancy body mass index (BMI) and adverse birth outcomes, and if they differ by HIV status. METHODS: We followed HIV-uninfected and -infected pregnant women initiating antiretroviral therapy (ART) from first antenatal visit through delivery. HIV-infected women initiated ART (tenofovir-emtricitabine/lamivudine-efavirenz) in pregnancy. Estimated pre-pregnancy BMI (kg/m2 ) was categorised as underweight (<18.5), normal (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0). We used modified Poisson regression to estimate risk ratios (RR) for associations between pre-pregnancy BMI and adverse birth outcomes and explored modification by HIV status. RESULTS: Among 1116 women (53% HIV-infected), 44% of HIV-uninfected women and 36% of HIV-infected women were classified as obese; 4% of women were underweight. Overall, 12% of infants were delivered preterm (<37 weeks), 10% small for gestational age (SGA, <10th percentile), and 9% large for gestational age (LGA, >90th percentile). Compared to HIV-uninfected women, HIV-infected women on ART had less LGA (5% vs 13%) but more SGA (12% vs 8%), and a similar proportion of preterm (13% vs 11%) infants. Pre-pregnancy BMI was not associated with preterm birth. Among HIV-uninfected women, obesity modestly increased the risk of LGA (RR 1.34, 95% confidence interval [CI] 0.82, 2.19), and underweight modestly elevated the risk of SGA (RR 1.66, 95% CI 0.79, 3.46). These associations were attenuated among HIV-infected women (RR 1.07, 95% CI 0.44, 2.64 for LGA, and RR 1.34, 95% CI 0.49, 3.64 for SGA). CONCLUSIONS: In this urban African setting of high HIV prevalence, pre-pregnancy obesity was common and did not vary by HIV status. In HIV-uninfected women, obesity increased the risk of LGA and being underweight the risk of SGA, compared with among HIV-uninfected women.

"You must leave but I didn't want to leave": qualitative evaluation of the integration of ART into postnatal maternal and child health services in Cape Town, South Africa.

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.

Changes in D-dimer after initiation of antiretroviral therapy in adults living with HIV in Kenya.

BACKGROUND: Increased coagulation biomarkers are associated with poor outcomes among people living with HIV (PLHIV). There are few data available from African cohorts demonstrating the effect of antiretroviral therapy (ART) on coagulation biomarkers. METHODS: From March 2014 to October 2014, ART-naïve PLHIV initiating non-nucleoside reverse transcriptase inhibitor-based ART were recruited from seven clinics in western Kenya and followed for up to 12 months. Demographics, clinical history and blood specimens were collected. Logistic regression models adjusted for intrasite clustering examined associations between HIV viral load and D-Dimer at baseline. Mixed linear effects models were used to estimate mean change from baseline to 6 months overall, and by baseline viral load, sex and TB status at enrollment. Mean change in D-dimer at 6 months is reported on the log10 scale and as percentage change from baseline. RESULTS: Among 611 PLHIV enrolled, 66% were female, median age was 34 years (interquartile range (IQR) 29-43 years), 31 (5%) participants had tuberculosis and median viral load was 113,500 copies/mL (IQR: 23,600-399,000). At baseline, 311 (50.9%) PLHIV had elevated D-dimer (> 500 ng/mL) and median D-dimer was 516.4 ng/mL (IQR: 302.7-926.6) (log baseline D-dimer: 2.7, IQR: 2.5-3.0). Higher baseline D-dimer was significantly associated with higher viral load (p < 0.0001), female sex (p = 0.02) and tuberculosis (p = 0.02). After 6 months on ART, 518 (84.8%) PLHIV had achieved viral load < 1000 copies/mL and median D-dimer was 390.0 (IQR: 236.6-656.9) (log D-dimer: 2.6, IQR: 2.4-2.8). Mean change in log D-dimer from baseline to 6 months was - 0.12 (95%CI -0.15, - 0.09) (p < 0.0001) indicating at 31.3% decline (95%CI -40.0, - 23.0) in D-dimer levels over the first 6 months on ART. D-dimer decline after ART initiation was significantly greater among PLHIV with tuberculosis at treatment initiation (- 172.1, 95%CI -259.0, - 106.3; p < 0.0001) and those with log viral load > 6.0 copies/mL (- 91.1, 95%CI -136.7, - 54.2; p < 0.01). CONCLUSIONS: In this large Kenyan cohort of PLHIV, women, those with tuberculosis and higher viral load had elevated baseline D-dimer. ART initiation and viral load suppression among ART-naïve PLHIV in Kenya were associated with significant decrease in D-dimer at 6 months in this large African cohort.

Community-based adherence clubs for postpartum women on antiretroviral therapy (ART) in Cape Town, South Africa: a pilot study.

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).

"This is My Life We are Talking About": Adaptive Strategies for HIV Care Retention and Treatment Adherence Among Postpartum Women Living with HIV in Cape Town, South Africa.

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.

Healthcare worker experiences with Option B+ for prevention of mother-to-child HIV transmission in eSwatini: findings from a two-year follow-up study.

BACKGROUND: Prevention of mother-to-child transmission (PMTCT) across sub-Saharan Africa has rapidly shifted towards Option B+, an approach in which all HIV+ pregnant and breastfeeding women initiate lifelong antiretroviral therapy (ART) independent of CD4+ count. Healthcare workers (HCW) are critical to the success of Option B+, yet little is known regarding HCW acceptability of Option B+, particularly over time. METHODS: Ten health facilities in the Manzini and Lubombo regions of eSwatini transitioned from Option A to Option B+ between 2013 and 2014 as part of the Safe Generations study examining PMTCT retention. Fifty HCWs (5 per facility) completed questionnaires assessing feasibility and acceptability: (1) prior to transitioning to Option B+, (2) two months post transition, and (3) approximately 2 years post Option B+ transition. This analysis describes HCW perceptions and experiences two years after transitioning to Option B+. RESULTS: Two years after transition, 80% of HCWs surveyed reported that Option B+ was easy for HCWs, noting that it was particularly easy to explain and coordinate. Immediate ART initiation also reduced delays by eliminating need for laboratory tests prior to ART initiation. Additionally, HCWs reported ease of patient follow-up (58%), documentation (56%), and counseling (58%) under Option B+. Findings also indicate that a majority of HCWs reported that their workloads increased under Option B+. Sixty-eight percent of HCWs at two years post-transition reported more work under Option B+, specifically noting increased involvement in adherence counseling, prescribing/monitoring medications, and appointment scheduling/tracking. Some HCWs attributed their higher workloads to increased client loads, now that all HIV-positive women were initiated on ART. New barriers to patient uptake, and issues related to retention, adherence, and follow-up were also noted as challenges face by HCW when implementing Option B+. CONCLUSIONS: Overall, HCWs found Option B+ to be acceptable and feasible while providing critical insights into the practical issues of universal ART. Further strengthening of the healthcare system may be necessary to alleviate worker burden and to ensure effective monitoring of client retention and adherence. HCW perceptions and experiences with Option B+ should be considered more broadly as countries implement Option B+ and consider universal treatment for all HIV+ individuals. TRIAL REGISTRATION: http://clinicaltrials.gov NCT01891799 , registered on July 3, 2013.

Integration of postpartum healthcare services for HIV-infected women and their infants in South Africa: A randomised controlled trial.

BACKGROUND: As the number of HIV-infected women initiating lifelong antiretroviral therapy (ART) during pregnancy increases globally, concerns have emerged regarding low levels of retention in HIV services and suboptimal adherence to ART during the postpartum period. We examined the impact of integrating postpartum ART for HIV+ mothers alongside infant follow-up within maternal and child health (MCH) services in Cape Town, South Africa. METHODS AND FINDINGS: We conducted a randomised trial among HIV+ postpartum women aged ≥18 years who initiated ART during pregnancy in the local antenatal care clinic and were breastfeeding when screened before 6 weeks postpartum. We compared an integrated postnatal service among mothers and their infants (the MCH-ART intervention) to the local standard of care (control)-immediate postnatal referral of HIV+ women on ART to general adult ART services and their infants to separate routine infant follow-up. Evaluation data were collected through medical records and trial measurement visits scheduled and located separately from healthcare services involved in either arm. The primary trial outcome was a composite endpoint of women's retention in ART care and viral suppression (VS) (viral load < 50 copies/ml) at 12 months postpartum; secondary outcomes included duration of any and exclusive breastfeeding, mother-to-child HIV transmission, and infant mortality. Between 5 June 2013 and 10 December 2014, a total of 471 mother-infant pairs were enrolled and randomised (mean age, 28.6 years; 18% nulliparous; 57% newly diagnosed with HIV in pregnancy; median duration of ART use at randomisation, 18 weeks). Among 411 women (87%) with primary endpoint data available, 77% of women (n = 155) randomised to the MCH-ART intervention achieved the primary composite outcome of retention in ART services with VS at 12 months postpartum, compared to 56% of women (n = 117) randomised to the control arm (absolute risk difference, 0.21; 95% CI: 0.12-0.30; p < 0.001). The findings for improved retention in care and VS among women in the MCH-ART intervention arm were consistent across subgroups of participants according to demographic and clinical characteristics. The median durations of any breastfeeding and exclusive breastfeeding were longer in women randomised to the intervention versus control arm (6.9 versus 3.0 months, p = 0.006, and 3.0 versus 1.4 months, p < 0.001, respectively). For the infants, overall HIV-free survival through 12 months of age was 97%: mother-to-child HIV transmission was 1.2% overall (n = 4 and n = 1 transmissions in the intervention and control arms, respectively), and infant mortality was 1.9% (n = 6 and n = 3 deaths in the intervention and control arms, respectively), and these outcomes were similar by trial arm. Interpretation of these findings should be qualified by the location of this study in a single urban area as well as the self-reported nature of breastfeeding outcomes. CONCLUSIONS: In this study, we found that integrating ART services into the MCH platform during the postnatal period was a simple and effective intervention, and this should be considered for improving maternal and child outcomes in the context of HIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT01933477.

Patterns and Predictors of HIV-Status Disclosure Among Pregnant Women in South Africa: Dimensions of Disclosure and Influence of Social and Economic Circumstances.

HIV-status disclosure may improve psychosocial health and adherence to antiretroviral therapy (ART), but existing insights suffer from methodological limitations. We explored disclosure over time during pregnancy and postpartum among 1347 HIV-positive women in Cape Town. Among 995 women diagnosed HIV-positive before the pregnancy and entering antenatal care (median age 30 years), 95% had disclosed to ≥ 1 individual. In Mokken scale analysis, we observed two separate dimensions of disclosure: disclosure to a male partner, and disclosure to family/community members. Among 352 women diagnosed during the pregnancy and initiating ART (median age 27 years), 61% disclosed to a male partner and 71% to a family/community member by 12 months after diagnosis. Relationship status modified the impact of pregnancy intentions and poverty on disclosure to a male partner. These unique data provide important insights into dimensions of disclosure during pregnancy and postpartum, and suggest that women's social and economic circumstances are central determinants of disclosure.

Determinants of suboptimal adherence and elevated HIV viral load in pregnant women already on antiretroviral therapy when entering antenatal care in Cape Town, South Africa.

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.

Experiences of HIV-positive postpartum women and health workers involved with community-based antiretroviral therapy adherence clubs in Cape Town, South Africa.

BACKGROUND: The rollout of universal, lifelong treatment for all HIV-positive pregnant and breastfeeding women ("Option B+") has rapidly increased the number of women initiating antiretroviral treatment (ART) and requiring ART care postpartum. In a pilot project in South Africa, eligible postpartum women were offered the choice of referral to the standard of care, a local primary health care clinic, or a community-based model of differentiated ART services, the adherence club (AC). ACs have typically enrolled only non-pregnant and non-postpartum adults; postpartum women had not previously been referred directly from antenatal care. There is little evidence regarding postpartum women's preferences for and experiences of differentiated models of care, or the capacity of this particular model to cater to their specific needs. This qualitative paper reports on feedback from both postpartum women and health workers who care for them on their respective experiences of the AC. METHODS: One-on-one in-depth qualitative interviews were conducted with 19 (23%) of the 84 postpartum women who selected the AC and were retained at approximately 12 months postpartum, and 9 health workers who staff the AC. Data were transcribed and thematically analysed using NVivo 11. RESULTS: Postpartum women's inclusion in the AC was acceptable for both participants and health workers. Health workers were welcoming of postpartum women but expressed concerns about prospects for longer term adherence and retention, and raised logistical issues they felt might compromise trust with AC members in general. CONCLUSIONS: Enrolling postpartum women in mixed groups with the general adult population is feasible and acceptable. Preliminary recommendations are offered and may assist in supporting the specific needs of postpartum women transitioning from antenatal ART care. TRIAL REGISTRATION: Number NCT02417675 clinicaltrials.gov/ct2/show/record/NCT02417675 (retrospective reg.).

Frequency of Viremic Episodes in HIV-Infected Women Initiating Antiretroviral Therapy During Pregnancy: A Cohort Study.

Background: The numbers of human immunodeficiency virus (HIV)-infected women initiating antiretroviral therapy (ART) in pregnancy are increasing rapidly with global policy changes. There are widespread concerns about ART adherence during pregnancy and postpartum but few data on viral suppression (VS) over time in these populations. Methods: We followed a cohort of 523 women in Cape Town, South Africa, initiating ART in pregnancy (once-daily tenofovir 300 mg, emtricitabine 200 mg, and efavirenz 600 mg) and achieving VS (<50 copies/mL). Participants provided specimens through 12 months postpartum for batched viral load (VL) testing separate from routine care. Analyses described the incidence of major (>1000 copies/mL) and minor (50-1000 copies/mL) viremic episodes (VEs) and factors associated with major VEs. Results: In the cohort (median age, 28 years; median pre-ART VL, 3.99 copies/mL; 3% previously defaulted ART; 24% with previous exposure to short-course antiretrovirals), the median time of follow-up from VS was 322 days. Overall, 70% maintained VS throughout follow-up, 8% experienced minor VEs only, and at least 1 major VE was documented in 22% of women. In women with VEs, peak viremia (median, 3.79 log10 copies/mL) was linearly related to pre-ART VL. The incidence of major VEs after initial VS was independently associated with younger age, ART initiation during the third trimester, previous defaulting on ART, and postpartum follow-up. Conclusions: Viremia appears to occur frequently, particularly postpartum, among HIV-infected women after initial VS in this setting. More intensive VL monitoring is warranted in this population; the immediate causes and long-term implications of VE require investigation.