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.
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.
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.
ClinicalTrials.gov NCT01933477.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Adolescents living with HIV (ALHIV) 15-19 years of age are a growing proportion of all people living with HIV globally and the population includes adolescents with vertically acquired HIV (AVH) and ...behaviorally acquired HIV (ABH).
We conducted a survey to measure sociodemographic characteristics, educational status, health history, and antiretroviral therapy (ART) adherence among a convenience sample of ALHIV at three government health facilities in 2019 in Nampula, Mozambique. ALHIV 15-19 years on ART, including females attending antenatal care, were eligible. Routine HIV care data were extracted from medical charts. Classification of ALHIV by mode of transmission was based on medical charts and survey data. ALHIV who initiated ART <15 years or reported no sex were considered AVH; all others ABH. Frequencies were compared by sex, and within sex, by mode of transmission (AVH vs. ABH) using Chi-square, Fishers exact tests and Wilcoxon rank-sum tests.
Among 208 ALHIV, 143 (69%) were female and median age was 18 years interquartile range (IQR) 16-19. Just over half of ALHIV (53%) were in or had completed secondary or higher levels of education; the most common reason for not being in school reported by 36% of females was pregnancy or having a child. Of all ALHIV, 122 (59%) had VL data, 62% of whom were <1000 copies/mL. Almost half (46%) of ALHIV reported missing ARVs ≥ 1 day in the past month (62% of males vs. 39% of females; p = 0.003). Just over half (58%) of ALHIV in relationships had disclosed their HIV status: 13% of males vs. 69% of females (p<0.001). Among sexually active males, 61% reported using a condom at last sex compared to 26% of females (p<0.001). Among female ALHIV, 50 (35%) were AVH and 93 (65%) were ABH, 67% of whom were not in school compared to 16% of ABH, (p<0.001).
Data from our study underscore the high level of deprivation among ALHIV enrolled in HIV care in Mozambique, as well as important disparities by sex and mode of transmission. These data can inform the development of effective interventions for this complex and important population.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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.
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.
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 (β = 1.57, 95% CI = 0.34-2.80, p = 0.01 and β = 1.57, 95% CI = 0.06-3.08, p = 0.04 respectively).
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.
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CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract
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.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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. From March 2014 to October 2014, ART-na#239;ve 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. 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). 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-na#239;ve PLHIV in Kenya were associated with significant decrease in D-dimer at 6 months in this large African cohort.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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.
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.
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).
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.
ClinicalTrials.gov NCT02417675 , April 16, 2015 (retrospectively registered).
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Dostopno za:
CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Introduction
Several HIV‐related syndemics have been described among adults. We investigated syndemic vulnerability to hazardous drinking (HD), intimate partner violence (IPV) and household food ...insecurity (HFIS) in breastfed children born without HIV in urban South Africa. We compared those who were perinatally HIV exposed (CHEU) to those who were not (CHU), under conditions of universal maternal antiretroviral therapy (ART) and breastfeeding.
Methods
A prospective cohort of pregnant women living with HIV (WLHIV), and without HIV, were enrolled and followed with their infants for 12 months postpartum (2013–2017). All WLHIV initiated antenatal efavirenz‐based ART. Measurements of growth (∼3 monthly), infectious cause hospitalisation, ambulatory childhood illness (2‐week recall) and neurodevelopment (BSID‐III, measured at ∼12 months’ age) were compared across bio‐social strata using generalised linear regression models, with interaction terms; maternal data included interview‐based measures for HD (AUDIT‐C), IPV (WHO VAW) and HFIS.
Results
Among 872 breastfeeding mother‐infant pairs (n = 461 CHEU, n = 411 CHU), WLHIV (vs. HIV negative) reported more unemployment (279/461, 60% vs. 217/411, 53%; p = 0.02), incomplete secondary education (347/461, 75% vs. 227/411, 55%; p < 0.0001), HD (25%, 117/459 vs. 7%, 30/411; p < 0.0001) and IPV (22%, 101/457 vs. 8%, 32/411; p < 0.0001) at enrolment; and HFIS at 12 months (45%, 172/386 vs. 30%, 105/352; p > 0.0001). There were positive interactions between maternal HIV and other characteristics. Compared to food secure CHU, the mean difference (95% CI) in weight‐for‐age Z‐score (WAZ) was 0.06 (−0.14; 0.25) for food insecure CHU; −0.26 (−0.42; −0.10) for food secure CHEU; and −0.43 (−0.61; −0.25), for food insecure CHEU. Results were similar for underweight (WAZ < −2), infectious‐cause hospitalisation, cognitive and motor delay. HIV‐IPV interactions were evident for ambulatory diarrhoea and motor delay. There were HIV‐HD interactions for odds of underweight, stunting, cognitive and motor delay. Compared to HD‐unexposed CHU, the odds ratios (95% CI) of underweight were 2.31 (1.11; 4.82) for HD‐exposed CHU; 3.57 (0.84; 15.13) for HD‐unexposed CHEU and 6.01 (2.22; 16.22) for HD‐exposed CHEU.
Conclusions
These data suggest that maternal HIV‐related syndemics may partly drive excess CHEU health risks, highlighting an urgent need for holistic maternal and family care and support alongside ART to optimise the health of CHEU.
Poor engagement in postpartum maternal HIV care is a challenge worldwide and contributes to adverse maternal outcomes and vertical transmission. Our objective was to project the clinical and economic ...impact of integrated postpartum maternal antiretroviral therapy (ART) and pediatric care in South Africa.
Using the CEPAC computer simulation models, parameterized with data from the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) randomized controlled trial, we evaluated the cost-effectiveness of integrated postpartum care for women initiating ART in pregnancy and their children. We compared two strategies: 1) standard of care (SOC) referral to local clinics after delivery for separate standard ART services for women and pediatric care for infants, and 2) the MCH-ART intervention (MCH-ART) of co-located maternal/pediatric care integrated in Maternal and Child Health (MCH) services throughout breastfeeding. Trial-derived inputs included: 12-month maternal retention in care and virologic suppression (SOC: 49%, MCH-ART: 67%), breastfeeding duration (SOC: 6 months, MCH-ART: 8 months), and postpartum healthcare costs for mother-infant pairs (SOC: $50, MCH-ART: $69). Outcomes included pediatric HIV infections, maternal and infant life expectancy (LE), lifetime HIV-related per-person costs, and incremental cost-effectiveness ratios (ICERs; ICER <US$903/YLS considered "cost-effective").
Compared to SOC, MCH-ART increased maternal LE (SOC: 25.26 years, MCH-ART: 26.20 years) and lifetime costs (SOC: $9,912, MCH-ART: $10,207; discounted). Projected pediatric outcomes for all HIV-exposed children were similar between arms, although undiscounted LE for HIV-infected children was shorter in SOC (SOC: 23.13 years, MCH-ART: 23.40 years). Combining discounted maternal and pediatric outcomes, the ICER was $599/YLS.
Co-located maternal HIV and pediatric care, integrated in MCH services throughout breastfeeding, is a cost-effective strategy to improve maternal and pediatric outcomes and should be implemented in South Africa.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Adolescents and youth living with HIV (AYAHIV) have worse HIV outcomes than other age groups, particularly in sub-Saharan Africa (SSA). AYAHIV in SSA face formidable health system, interpersonal- and ...individual-level barriers to retention in HIV care, uptake of ART, and achievement of viral suppression (VS), underscoring an urgent need for multi-component interventions to address these challenges. This cluster-randomized control trial (cRCT) aims to evaluate the effectiveness and monitor implementation of a community-informed multi-component intervention ("CombinADO strategy") addressing individual-, facility-, and community-level factors to improve health outcomes for AYAHIV.
This trial will be conducted in 12 clinics in Nampula Province, Northern Mozambique. All clinics will implement an optimized standard of care (control) including (1) billboards/posters and radio shows, (2) healthcare worker (HCW) training, (3) one-stop adolescent and youth-friendly services, (4) information/motivation walls, (5) pill containers, and (6) tools to be used by HCW during clinical visits. The CombinADO strategy (intervention) will be superadded to control conditions at 6 randomly selected clinics. It will include five additional components: (1) peer support, (2) informational/motivational video, (3) support groups for AYAHIV caregivers, (4) AYAHIV support groups, and (5) mental health screening and linkage to adolescent-focused mental health support. The study conditions will be in place for 12 months; all AYAHIV (ages 10-24 years, on ART) seeking care in the participating sites will be exposed to either the control or intervention condition based on the clinic they attend. The primary outcome is VS (viral load < 50 copies/mL) at 12 months among AYAHIV attending participating clinics. Secondary outcomes include ART adherence (self-reported and TDF levels) and retention in care (engagement in the preceding 90 days). Uptake, feasibility, acceptability, and fidelity of the CombinADO strategy during implementation will be measured. Trial outcomes will be assessed in AYAHIV, caregivers, healthcare workers, and key informants. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cRCTs.
The CombinADO study will provide evidence on effectiveness and inform implementation of a novel community-informed multi-component intervention to improve retention, adherence, and VS among AYAHIV. If found effective, results will strengthen the rationale for scale up in SSA.
ClinicalTrials.gov NCT04930367 . Registered on 18 June 2021.
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.
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.
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.
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.
Number NCT02417675 clinicaltrials.gov/ct2/show/record/NCT02417675 (retrospective reg.).
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Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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