RESUMEN
BACKGROUND: Evidence suggests that disclosure of HIV status between partners may influence prevention of maternal-to-child transmission of HIV (PMTCT) outcomes. We report partner disclosure in relation to maternal antiretroviral therapy (ART) uptake and adherence, and MTCT among postpartum HIV-infected Malawian women. METHODS: A cross-sectional mixed-method study was conducted as part of a nationally representative longitudinal cohort study. Between 2014-2016, all (34,637) mothers attending 54 under-5 clinics with their 4-26 week-old infants were approached, of which 98% (33,980) were screened for HIV; infants received HIV-1 DNA testing. HIV-exposure was confirmed in 3,566/33,980 (10.5%). Baseline data from mothers who were known to be HIV-infected at time of screening were included in the current analysis. Guardians (n = 17), newly diagnosed HIV-infected mothers (n = 256) and mothers or infants with undetermined HIV status (n = 30) were excluded. Data collected included socio-demographics, partner disclosure, maternal ART uptake, and adherence. Between 2016-2017, in-depth interviews and focus group discussions were conducted with adult mothers (n = 53) and their spouse/cohabiting partners (n = 19), adolescent mothers (n = 13), lost-to-follow up (LTFU) mothers (n = 22), community leaders (n = 23) and healthcare workers (n = 154). RESULTS: Of 3153 known HIV-infected mothers, 2882 (91.4%) reported having a spouse/cohabiting partner. Among 2882 couples, both partners, one partner, and neither partner disclosed to each other in 2090 (72.5%), 622 (21.6%), and 169 (5.9%), respectively. In multivariable models, neither partner disclosing was associated with no maternal ART (aOR 4.7; 95%CI 2.5-8.8), suboptimal treatment adherence (aOR 1.8; 95%CI 1.1-2.8) and MTCT (aOR 2.1; 95%CI 1.1-4.1). Women's fear of blame by partners was central to decisions not to disclose within couples and when starting new relationships. LTFU mothers struggled to accept and disclose their status, hindering treatment initiation; some were unable to hide ART and feared involuntary disclosure. CONCLUSION: Partner disclosure seems to play an important role in women's decisions regarding ART initiation and adherence. Inter-partner non-disclosure was associated with no ART uptake, suboptimal treatment adherence and MTCT.
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Antirretrovirales/uso terapéutico , Revelación/estadística & datos numéricos , Infecciones por VIH/epidemiología , Transmisión Vertical de Enfermedad Infecciosa/estadística & datos numéricos , Complicaciones Infecciosas del Embarazo/epidemiología , Adulto , Estudios Transversales , Femenino , Infecciones por VIH/diagnóstico , Infecciones por VIH/tratamiento farmacológico , Humanos , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Estudios Longitudinales , Perdida de Seguimiento , Malaui/epidemiología , Cooperación del Paciente/estadística & datos numéricos , Embarazo , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Parejas Sexuales , Adulto JovenRESUMEN
BACKGROUND: Malawi introduced an ambitious public health program known as "Option B+" which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of WHO clinical stage or CD4 cell count. The PMTCT Uptake and REtention (PURE) study aimed at evaluating the effect of peer-support on care-seeking and retention in care. METHODS/DESIGN: PURE Malawi was a three-arm cluster randomized controlled trial that compared facility-based and community-based models of peer support to standard of care under Option B+ strategy. Each arm was expected to enroll a minimum of 360 women with a total minimum sample size of 1080 participants. 21 sites (clusters) were selected for inclusion in the study. This paper describes the site selection, recruitment, enrollment process and baseline characteristics of study sites and women enrolled in the trial. RESULTS: Study implementation was managed by 3 partner organizations; each responsible for 7 study sites. The trial was conducted in the South East, South West, and Central West zones of Malawi, the zones where the implementing partners operate. Study sites included 2 district hospitals, 2 mission hospitals, 2 rural hospitals, 13 health centers and 1 private clinic. Enrollment occurred from November 2013 to November 2014, over a median period of 31 weeks (range 17-51) by site. A total of 1269 HIV-infected pregnant (1094) and breastfeeding (175) women, who were eligible to initiate ART under Option B+, were enrolled. Each site reached or surpassed the minimum sample size. Comparing the number of women enrolled versus antenatal cohort reports, sites recruited a median of 90% (IQR 75-100) of eligible reported women. In the majority of sites the ratio of pregnant and lactating women enrolled in the study was similar to the ratio of reported pregnant and lactating women starting ART in the same sites. The median age of all women was 27 (IQR 22-31) years. All women have ≥20 months of possible follow-up time; 96% ≥ 2 years (24-32 months). CONCLUSION: The PURE Malawi study showed that 3 implementing partner organizations could successfully recruit a complex cohort of pregnant and lactating women across 3 geographical zones in Malawi within a reasonable timeline. TRIAL REGISTRATION: This study is registered at clinicaltrials.gov - ID Number NCT02005835 . Registered 4 December, 2013.
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Antirretrovirales/uso terapéutico , Infecciones por VIH/transmisión , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Salud Pública , Apoyo Social , Adulto , Antirretrovirales/farmacocinética , Femenino , Infecciones por VIH/tratamiento farmacológico , Humanos , Malaui , EmbarazoRESUMEN
BACKGROUND: Many sub-Saharan African countries have adopted Option B+, a prevention of mother-to-child transmission approach providing HIV-infected pregnant and lactating women with immediate lifelong antiretroviral therapy. High maternal attrition has been observed in Option B+. Peer-based support may improve retention. METHODS: A 3-arm stratified cluster randomized controlled trial was conducted in Malawi to assess whether facility- and community-based peer support would improve Option B+ uptake and retention compared with standard of care (SOC). In SOC, no enhancements were made (control). In facility-based and community-based models, peers provided patient education, support groups, and patient tracing. Uptake was defined as attending a second scheduled follow-up visit. Retention was defined as being alive and in-care at 2 years without defaulting. Attrition was defined as death, default, or stopping antiretroviral therapy. Generalized estimating equations were used to estimate risk differences (RDs) in uptake. Cox proportional hazards regression with shared frailties was used to estimate hazard of attrition. RESULTS: Twenty-one facilities were randomized and enrolled 1269 women: 447, 428, and 394 in facilities that implemented SOC, facility-based, and community-based peer support models, respectively. Mean age was 27 years. Uptake was higher in facility-based (86%; RD: 6%, confidence interval [CI]: -3% to 15%) and community-based (90%; RD: 9%, CI: 1% to 18%) models compared with SOC (81%). At 24 months, retention was higher in facility-based (80%; RD: 13%, CI: 1% to 26%) and community-based (83%; RD: 16%, CI: 3% to 30%) models compared with SOC (66%). CONCLUSIONS: Facility- and community-based peer support interventions can benefit maternal uptake and retention in Option B+.
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Fármacos Anti-VIH/uso terapéutico , Servicios de Salud Comunitaria , Infecciones por VIH/tratamiento farmacológico , Accesibilidad a los Servicios de Salud/organización & administración , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Madres , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Adulto , Terapia Antirretroviral Altamente Activa/métodos , Análisis por Conglomerados , Servicios de Salud Comunitaria/organización & administración , Femenino , Infecciones por VIH/prevención & control , Infecciones por VIH/transmisión , Investigación sobre Servicios de Salud , Humanos , Malaui/epidemiología , Grupo Paritario , Embarazo , Complicaciones Infecciosas del Embarazo/prevención & control , Evaluación de Programas y Proyectos de Salud , Apoyo Social , Adulto JovenRESUMEN
BACKGROUND: In 2011, Malawi launched Option B+, a program of universal antiretroviral therapy (ART) treatment for pregnant and lactating women to optimize maternal health and prevent pediatric HIV infection. For optimal outcomes, women need to achieve HIVRNA suppression. We report 6-month HIVRNA suppression and HIV drug resistance in the PURE study. METHODS: PURE study was a cluster-randomized controlled trial evaluating 3 strategies for promoting uptake and retention; arm 1: Standard of Care, arm 2: Facility Peer Support, and arm 3: Community Peer support. Pregnant and breastfeeding mothers were enrolled and followed according to Malawi ART guidelines. Dried blood spots for HIVRNA testing were collected at 6 months. Samples with ART failure (HIVRNA ≥1000 copies/ml) had resistance testing. We calculated odds ratios for ART failure using generalized estimating equations with a logit link and binomial distribution. RESULTS: We enrolled 1269 women across 21 sites in Southern and Central Malawi. Most enrolled while pregnant (86%) and were WHO stage 1 (95%). At 6 months, 950/1269 (75%) were retained; 833/950 (88%) had HIVRNA testing conducted, and 699/833 (84%) were suppressed. Among those with HIVRNA ≥1000 copies/ml with successful amplification (N = 55, 41% of all viral loads > 1000 copies/ml), confirmed HIV resistance was found in 35% (19/55), primarily to the nonnucleoside reverse transcriptase inhibitor class of drugs. ART failure was associated with treatment default but not study arm, age, WHO stage, or breastfeeding status. CONCLUSIONS: Virologic suppression at 6 months was <90% target, but the observed confirmed resistance rates suggest that adherence support should be the primary approach for early failure in option B+.
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Fármacos Anti-VIH/uso terapéutico , Resistencia a Medicamentos/efectos de los fármacos , Infecciones por VIH/tratamiento farmacológico , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Servicios de Salud Materno-Infantil , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Organización Mundial de la Salud , Adulto , Lactancia Materna , Recuento de Linfocito CD4 , Análisis por Conglomerados , Femenino , Infecciones por VIH/prevención & control , Infecciones por VIH/transmisión , Humanos , Recién Nacido , Malaui/epidemiología , Cumplimiento de la Medicación/estadística & datos numéricos , Embarazo , Complicaciones Infecciosas del Embarazo/prevención & control , Evaluación de Programas y Proyectos de Salud , Carga Viral , Adulto JovenRESUMEN
INTRODUCTION: Malawi has embarked on a "test-and-treat" approach to prevent mother-to-child transmission (PMTCT) of HIV, known as "Option B+," offering all HIV-infected pregnant and breastfeeding women lifelong antiretroviral therapy (ART) regardless of CD4 count or clinical stage. A cross-sectional qualitative study was conducted to explore early experiences surrounding "Option B+" for patients and health care workers (HCWs) in Malawi. METHODS: Study participants were purposively selected across 6 health facilities in 3 regional health zones in Malawi. Semi-structured interviews were conducted with women enrolled in "Option B+" (n = 24), and focus group discussions were conducted with HCWs providing Option B+ services (n = 6 groups of 8 HCWs). Data were analyzed using a qualitative thematic coding framework. RESULTS: Patients and HCWs identified the lack of male involvement as a barrier to retention in care and expressed concerns at the rapidity of the test-and-treat process, which makes it difficult for patients to "digest" a positive diagnosis before starting ART. Fear regarding the breach of privacy and confidentiality were also identified as contributing to loss to follow-up of women initiated under the Option B+. Disclosure remains a difficult process within families and couples. Lifelong ART was also perceived as an opportunity to plan future pregnancies. CONCLUSIONS: As "Option B+" continues to be rolled out, novel interventions to support and retain women into care must be implemented. These include providing space, time, and support to accept a diagnosis before starting ART, engaging partners and families, and addressing the need for peer support and confidentiality.
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Antirretrovirales/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Personal de Salud , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Madres , Aceptación de la Atención de Salud , Adulto , Lactancia Materna , Estudios Transversales , Femenino , Infecciones por VIH/diagnóstico , Humanos , Entrevistas como Asunto , Malaui , Periodo Posparto , Embarazo , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Adulto JovenRESUMEN
BACKGROUND: Informal care, the health care provided by the patient's social network is important in low income settings although its monetary value is rarely estimated. The lack of estimates of the value of informal care has led to its omission in economic evaluations but this can result in incorrect decisions about cost effectiveness of an intervention. We explore the use of contingent valuation methods of willingness to pay (WTP) and willingness to accept (WTA) to estimate the value of informal care provided to HIV infected women that are accessing antiretroviral therapy (ART) under the Option B+ approach to prevention of mother-to-child transmission (PMTCT) of HIV in Malawi. METHODS: We collected cross sectional data from 93 caregivers of women that received ART care from six health facilities in Malawi. Caregivers of women that reported for ART care on the survey day and consented to participate in the survey were included until the targeted sample size for the facility was reached. We estimated the value of informal care by using the willingness to accept (WTA) and willingness to pay (WTP) approaches. Medians were used to summarize the values and these were compared by the Wilcoxon signed-rank test. RESULTS: The median WTA to provide informal care in a month was US$30 and the median WTP for informal care was US$13 and the two were statistically different (p < 0.000). Median WTP was higher in the urban areas than in the rural areas (US$21 vs. US$13, p < 0.001) and for caregivers from households from higher wealth quintile than in the lower quintile (US$15 vs. US$13, p < 0.0462). CONCLUSION: Informal caregivers place substantial value on informal care giving. In low income settings where most caregivers are not formally employed, WTP and WTA approaches can be used to value informal care. CLINICAL TRIAL NUMBER: NCT02005835.
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Fármacos Anti-VIH/uso terapéutico , Infecciones por VIH/prevención & control , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Atención al Paciente/economía , Complicaciones Infecciosas del Embarazo/prevención & control , Adulto , Fármacos Anti-VIH/economía , Cuidadores/economía , Estudios Transversales , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/economía , Gastos en Salud/estadística & datos numéricos , Humanos , Transmisión Vertical de Enfermedad Infecciosa/economía , Malaui , Masculino , Aceptación de la Atención de Salud , Atención al Paciente/normas , Embarazo , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Encuestas y Cuestionarios , Factores de TiempoRESUMEN
In July 2011, Malawi introduced an ambitious public health program known as "Option B+," which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of clinical stage or CD4 count. Option B+ is expected to have benefits for HIV-infected women, their HIV-exposed infants, and their HIV-uninfected male sex partners. However, these benefits hinge on early uptake of prevention of mother-to-child transmission, good adherence, and long-term retention in care. The Prevention of mother-to-child transmission Uptake and REtention (PURE) study is a 3-arm cluster randomized controlled trial to evaluate whether clinic- or community-based peer support will improve care-seeking and retention in care by HIV-infected pregnant and breastfeeding women, their HIV-exposed infants, and their male sex partners, and ultimately improve health outcomes in all 3 populations. We describe the PURE Malawi Consortium, the initial work conducted to inform the trial and interventions, the trial design, and the analysis plan. We then discuss concerns and expected contributions to Malawi and the region.