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Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial.

ABSTRACT: BACKGROUND:Antiretroviral therapy (ART) and retention in care are essential for the prevention of mother-to-child HIV transmission (PMTCT). We aimed to assess the effect of a family-focused, integrated PMTCT care package. METHODS:In this parallel, cluster-randomised controlled trial, we pair-matched 12 primary and secondary level health-care facilities located in rural north-central Nigeria. Clinic pairs were randomly assigned to intervention or standard of care (control) by computer-generated sequence. HIV-infected women (and their infants) presenting for antenatal care or delivery were included if they had unknown HIV status at presentation (there was no age limit for the study, but the youngest participant was 16 years old); history of antiretroviral prophylaxis or treatment, but not receiving these at presentation; or known HIV status but had never received treatment. Standard of care included health information, opt-out HIV testing, infant feeding counselling, referral for CD4 cell counts and treatment, home-based services, antiretroviral prophylaxis, and early infant diagnosis. The intervention package added task shifting, point-of-care CD4 testing, integrated mother and infant service provision, and male partner and community engagement. The primary outcomes were the proportion of eligible women who initiated ART and the proportion of women and their infants retained in care at 6 weeks and 12 weeks post partum (assessed by generalised linear mixed effects model with random effects for matched clinic pairs). The trial is registered with ClinicalTrials.gov, number NCT01805752. FINDINGS:Between April 1, 2013, and March 31, 2014, we enrolled 369 eligible women (172 intervention, 197 control), similar across groups for marital status, duration of HIV diagnosis, and distance to facility. Median CD4 count was 424 cells per ?L (IQR 268-606) in the intervention group and 314 cells per ?L (245-406) in the control group (p<0·0001). Of the 369 women included in the study, 363 (98%) had WHO clinical stage 1 disease, 364 (99%) had high functional status, and 353 (96%) delivered vaginally. Mothers in the intervention group were more likely to initiate ART (166 [97%] vs 77 [39%]; adjusted relative risk 3·3, 95% CI 1·4-7·8). Mother and infant pairs in the intervention group were more likely to be retained in care at 6 weeks (125 [83%] of 150 vs 15 [9%] of 170; adjusted relative risk 9·1, 5·2-15·9) and 12 weeks (112 [75%] of 150 vs 11 [7%] of 168 pairs; 10·3, 5·4-19·7) post partum. INTERPRETATION:This integrated, family-focused PMTCT service package improved maternal ART initiation and mother and infant retention in care. An effective approach to improve the quality of PMTCT service delivery will positively affect global goals for the elimination of mother-to-child HIV transmission. FUNDING:Eunice Kennedy Shriver National Institute of Child Health and Human Development and US National Institutes of Health.

SUBMITTER: Aliyu MH

PROVIDER: S-EPMC4852280 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial.

Aliyu Muktar H MH Blevins Meridith M Audet Carolyn M CM Kalish Marcia M Gebi Usman I UI Onwujekwe Obinna O Lindegren Mary Lou ML Shepherd Bryan E BE Wester C William CW Vermund Sten H SH

The lancet. HIV 20160224 5

<h4>Background</h4>Antiretroviral therapy (ART) and retention in care are essential for the prevention of mother-to-child HIV transmission (PMTCT). We aimed to assess the effect of a family-focused, integrated PMTCT care package.<h4>Methods</h4>In this parallel, cluster-randomised controlled trial, we pair-matched 12 primary and secondary level health-care facilities located in rural north-central Nigeria. Clinic pairs were randomly assigned to intervention or standard of care (control) by compu ...[more]

PMID: 27126487

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Project description:BackgroundHigh mother-to-child HIV transmission rates in Nigeria are coupled with a critical shortage of trained health personnel, dearth of infrastructure, and low levels of male involvement in HIV care. This study evaluated maternal and provider satisfaction with services for prevention of mother-to-child transmission within the context of an implementation science cluster-randomized trial that included task shifting to lower-cadre workers, male engagement, point-of-care CD4 cell counts, and integrated mother-infant care.MethodsPatient and clinician satisfaction were measured at 6 control and 6 intervention sites using a 5-point Likert scale. Patient satisfaction was assessed at 6 weeks postpartum through a 22-item scale about the provider's ability to explain the health problem, time spent with the clinician, and motivation to follow prescribed treatment. Provider satisfaction was assessed through a 12-item scale about motivation, compensation, and training, with 4 additional questions about the impact of task shifting on job satisfaction to intervention arm providers.ResultsWe measured satisfaction among 340 mothers (intervention n = 160; control n = 180) and 60 providers (intervention n = 36; control n = 24). Total patient satisfaction (maximum 5) was higher in the intervention than control arm [median (interquartile range) = 4.61 (4.22-4.79) vs. 3.84 (3.22-4.22), respectively; P < 0.001]. Provider satisfaction was generally high, and was similar between the intervention and the control arms [median (interquartile range) = 3.60 (3.37-3.91) vs. 3.50 (3.08-4.25), respectively; P = 0.69]. Provider satisfaction dropped when questions on newly acquired provider roles were included [3.47 (3.25-3.72)]. Patient and provider satisfaction were not associated with uptake of antiretroviral therapy or mother-infant retention at 6 and 12 weeks postpartum.ConclusionsSatisfaction was higher among patients at intervention sites, and provider satisfaction decreased when newly assigned roles were factored in. Task shifting should include training and supportive oversight to ensure comfort with assigned tasks.

Project description:BackgroundTimely diagnosis of infant HIV infection is essential for antiretroviral therapy (ART) initiation. In a randomized controlled trial, we found the Texting Improves Testing (TextIT) intervention (a theory-based text messaging system) to be efficacious for improving infant HIV testing rates and maternal retention in prevention of mother-to-child HIV transmission (PMTCT) programs. Using an implementation science approach, we aimed to evaluate real-world effectiveness of the intervention.Methods and findingsIn a pragmatic, cluster-randomized, stepped-wedge trial with 2 time periods of observation, we randomly allocated 10 clinics to begin implementing the intervention immediately and 10 clinics to begin implementing 6 months later. To approximate real-world conditions, inclusion criteria were broad. Women at clinics implementing the intervention received up to 14 text messages during pregnancy and after delivery and had the option to respond to text messages, call, or send inquiry text messages to a designated clinic phone. The primary outcomes were infant HIV testing and maternal retention in care during the first 8 weeks after delivery. We used modified Poisson regression with robust variance estimation to estimate the relative risk and 95% confidence intervals (CIs). Generalized estimating equations were applied on individual-level data to account for clustering by site. Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included. Participant characteristics at enrollment did not differ by study arm. Overall median age was 27 years (interquartile range [IQR] 23-30), median gestational age was 30 weeks (IQR 28-34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone. Of 2,326 infants analyzed, 1,466 of 1,613 (90.9%) in the intervention group and 609 of 713 (85.4%) in the control group met the primary outcome of HIV virologic testing performed before 8 weeks after birth (adjusted relative risk [aRR] 1.03; 95% CI 0.97-1.10; P = 0.3). Of 2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery (aRR 1.12; 95% CI 0.97-1.30; P = 0.1). This study had two main limitations. Staff at all facilities were aware of ongoing observation, which may have contributed to increased rates of infant HIV testing and maternal retention in care at both intervention and control facilities, and programmatic initiatives to improve maternal and infant retention in care were ongoing at all facilities at the time of this study, which likely limited the ability to demonstrate effectiveness of the trial intervention.ConclusionsIn this study, a larger proportion of infants in the intervention group received HIV testing compared with the control group, but the difference was small and not statistically significant. There was also a nonsignificant increase in maternal postpartum retention in the intervention periods. Despite the lack of a significant effect of the intervention, key lessons emerged, both for strengthening PMTCT and for implementation research in general. Perhaps most important, improving the implementation of usual care may have been sufficient to substantially improve infant HIV testing rates.Trial registrationClinicalTrials.gov Trial Number NCT02350140.

Project description:BackgroundPoor 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.MethodsUsing 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").ResultsCompared 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.ConclusionCo-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.

Project description:BackgroundNigeria has low antiretroviral therapy (ART) coverage among HIV-positive pregnant women. In a previous cluster-randomized trial in Nigeria, Baby Shower events resulted in higher HIV testing coverage and linkage of pregnant women to ART; here, we assess outcomes of Baby Shower events in a non-research setting.MethodsBaby Shower events, including a prayer ceremony, group education, music, gifting of a "mama pack" with safe delivery supplies, and HIV testing with ART linkage support for HIV-positive pregnant women, were conducted in eighty sites in Benue State, Nigeria. Client questionnaires (including demographics, ANC attendance, and HIV testing history), HIV test results, and reported linkage to ART were analyzed. Descriptive data on HIV testing and ART linkage data for facility-based care at ANC clinics in Benue State were also analyzed for comparison.ResultsBetween July 2016 and October 2017, 10,056 pregnant women and 6,187 male partners participated in Baby Shower events; 61.5% of women attended with a male partner. Nearly half of female participants (n = 4515, 44.9%) were not enrolled in ANC for the current pregnancy, and 22.3% (n = 2,241) of female and 24.8% (n = 1,532) of male participants reported they had never been tested for HIV. Over 99% (n = 16,240) of participants had their HIV status ascertained, with 7.2% of females (n = 724) and 4.0% of males (n = 249) testing HIV-positive, and 2.9% of females (n = 274) and 2.3% of males (n = 138) receiving new HIV-positive diagnoses. The majority of HIV-positive pregnant women (93.0%, 673/724) were linked to ART. By comparison, at health facilities in Benue State during a similar time period, 99.7% of pregnant women had HIV status ascertained, 8.4% had a HIV-positive status, 2.1% were newly diagnosed HIV-positive, and 100% were linked to ART.ConclusionCommunity-based programs such as the faith-based Baby Shower intervention complement facility-based approaches and can reach individuals who would not otherwise access facility-based care. Future Baby Showers implementation should incorporate enhanced support for ART linkage and retention to maximize the impact of this intervention on vertical HIV transmission.

Project description:Zimbabwe has made large strides in addressing HIV. To ensure a continued robust response, a clear understanding of costs associated with its HIV program is critical. We conducted a cross-sectional evaluation in 2017 to estimate the annual average patient cost for accessing Prevention of Mother-To-Child Transmission (PMTCT) services (through antenatal care) and Antiretroviral Treatment (ART) services in Zimbabwe. Twenty sites representing different types of public health facilities in Zimbabwe were included. Data on patient costs were collected through in-person interviews with 414 ART and 424 PMTCT adult patients and through telephone interviews with 38 ART and 47 PMTCT adult patients who had missed their last appointment. The mean and median annual patient costs were examined overall and by service type for all participants and for those who paid any cost. Potential patient costs related to time lost were calculated by multiplying the total time to access services (travel time, waiting time, and clinic visit duration) by potential earnings (US$75 per month assuming 8 hours per day and 5 days per week). Mean annual patient costs for accessing services for the participants was US$20.00 [standard deviation (SD) = US$80.42, median = US$6.00, range = US$0.00-US$12,18.00] for PMTCT and US$18.73 (SD = US$58.54, median = US$8.00, range = US$0.00-US$ 908.00) for ART patients. The mean annual direct medical costs for PMTCT and ART were US$9.78 (SD = US$78.58, median = US$0.00, range = US$0.00-US$ 90) and US$7.49 (SD = US$60.00, median = US$0.00) while mean annual direct non-medical cost for US$10.23 (SD = US$17.35, median = US$4.00) and US$11.23 (SD = US$25.22, median = US$6.00, range = US$0.00-US$ 360.00). The PMTCT and ART costs per visit based on time lost were US$3.53 (US$1.13 to US$8.69) and US$3.43 (US$1.14 to US$8.53), respectively. The mean annual patient costs per person for PMTCT and ART in this evaluation will impact household income since PMTCT and ART services in Zimbabwe are supposed to be free.

Project description:This study was conducted to assess the impact of the eye care programme on cataract blindness and cataract surgical services in Sokoto, Nigeria over a 12 year period 2005-2016.Data from the 2005 population based cross-sectional study of blindness in Sokoto state was re-analysed to obtain baseline estimates of the prevalence of cataract blindness and cataract surgical coverage for persons 50 years and over in Wurno health zone. A population based survey of a representative sample of persons 50 years and over in Wurno health zone was conducted in July 2016. Data on eye health workforce, infrastructure and cataract surgical services between 2005 and 2016 were analysed from relevant documents.In 2005 the unadjusted prevalence of bilateral cataract blindness (<3/60) in people 50 years and over in Wurno health zone was 5.6% (95% CI: 3.1, 10.1). By 2016 this had fallen to 2.1% (95% CI 1.5%, 2.7%), with the age-sex adjusted prevalence being 1.9% (95% CI 1.3%, 2.5%). The CSC for persons with visual acuity <3/60, <6/60, <6/18 for Wurno health zone was 9.1%, 7.1% and 5.5% respectively in 2005 and this had increased to 67.3%, 62.1% and 34.7% respectively in 2016. The CSR in Sokoto state increased from 272 (1005 operations) in 2006, to 596 (2799 operations) in 2014. In the 2005 survey, couching (a procedure used by traditional practitioners to dislocate the lens into the vitreous cavity) accounted for 87.5% of all cataract interventions, compared to 45.8% in the 2016 survey participants. In 2016 18% of eyes having a cataract operation with IOL implantation had a presenting visual acuity of <6/60 (poor outcome) with the main causes being postoperative complications (53%) and uncorrected refractive error (29%).Between 2005 and 2016 there was a doubling in cataract surgical rate, a 7 times increase in cataract surgical coverage (<3/60), and a decrease in cataract blindness and the proportion of eyes being couched. However, there remains a high prevalence of un-operated cataract in 2016 indicating a need to further improve access to affordable and good quality cataract surgical services.

Dataset Information

Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial.

Publications

Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial.

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