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Prospective comparison of two models of integrating early infant male circumcision with maternal child health services in Kenya: The Mtoto Msafi Mbili Study.

ABSTRACT: As countries scale up adult voluntary medical male circumcision (VMMC) for HIV prevention, they are looking ahead to long term sustainable strategies, including introduction of early infant male circumcision (EIMC). To address the lack of evidence regarding introduction of EIMC services in sub-Saharan African settings, we conducted a simultaneous, prospective comparison of two models of EIMC service delivery in Homa Bay County, Kenya. In one division a standard delivery package (SDP) was introduced and included health facility-based provision of EIMC services with community engagement for client referral versus in a different division a standard package plus (SDPplus) that included community-delivered EIMC services. Babies 1-60 days old were eligible for EIMC. A representative sample of mothers and fathers of baby boys at 16 health facilities was surveyed. We examined differences between mothers and fathers in the SDP and SDPplus divisions and identified factors associated with EIMC uptake. We report adjusted prevalence ratios (aPR). Of 1660 mothers interviewed, 1501 (89%) gave approval to contact the father, and 1259 fathers (84%) were interviewed. The proportion of babies circumcised was slightly greater in the SDPplus division than the SDP division (27.3% vs 23.7%), but the difference was not significant (p = 0.08). In adjusted analyses, however, the prevalence of babies being circumcised was greater in the SDPplus division (aPR = 1.23, 95% CI:1.04-1.45) and the factors associated with a baby being circumcised were the mother having received information about EIMC (during pregnancy, aPR = 4.81, 95% CI: 2.21-3.42), having discussed circumcision with the father if married or cohabiting (aPR = 5.39, 95% CI: 3.31-8.80) or being single (aPR = 5.67, 95% CI: 3.31-9.69), perceiving herself to be living with HIV (aPR = 1.39, 95% CI: 1.15-1.67), or having a post-secondary education (aPR = 1.33, 95% CI: 1.04-1.69), and the father being Muslim (aPR = 1.85, 95% CI: 1.29-2.65) or circumcised (aPR = 1.34, 95% CI: 1.13-1.59). The median age of 2117 babies circumcised was 8 days (IQR: 1-36), and the median weight was 3.6 kg (IQR: 3.2-4.4). There were 6 moderate adverse events (AEs) (0.28%); 5 severe AEs (0.24%), all involving an injury to the glans penis, requiring hospitalization and corrective surgery; and one death probably related to the procedure. There were no AEs among the 365 procedures performed outside health facilities. Information and education campaigns must reach members of the general population, especially men and fathers, who are influential to the EIMC decision. Serious AEs using the Mogen clamp are rare, but do occur and require efficient, reliable emergency back-up. Our results can assist countries considering scale-up of EIMC services for HIV prevention as their adult VMMC programs mature.

SUBMITTER: Bailey RC

PROVIDER: S-EPMC5589171 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Prospective comparison of two models of integrating early infant male circumcision with maternal child health services in Kenya: The Mtoto Msafi Mbili Study.

Bailey Robert C RC Adera Fredrick F Mackesy-Amiti Mary Ellen ME Adipo Timothy T Nordstrom Sherry K SK Mehta Supriya D SD Jaoko Walter W Langi F L Fredrik G FLFG Obiero Walter W Obat Edmon E Otieno Fredrick O FO Young Marisa R MR

PloS one 20170907 9

As countries scale up adult voluntary medical male circumcision (VMMC) for HIV prevention, they are looking ahead to long term sustainable strategies, including introduction of early infant male circumcision (EIMC). To address the lack of evidence regarding introduction of EIMC services in sub-Saharan African settings, we conducted a simultaneous, prospective comparison of two models of EIMC service delivery in Homa Bay County, Kenya. In one division a standard delivery package (SDP) was introdu ...[more]

PMID: 28880904

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Project description:Background: 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.Methods: 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").Results: 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.Conclusion: 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.

Project description:Voluntary medical male circumcision is a crucial HIV prevention program for men in sub-Saharan Africa. Kenya is one of the first countries to achieve high population coverage and seek to transition the program to a more sustainable structure designed to maintain coverage while making all aspects of service provision domestically owned and implemented. Using pre-defined metrics, we created and evaluated three models of circumcision service delivery (static, mobile and mixed) to identify which had potential for sustaining high circumcision coverage among 10-14-year-olds group, a historically high-demand and accessible age group, at the lowest possible cost. We implemented each model in two distinct geographic areas, one in Siaya and the other in Migori county, and assessed multiple aspects of each model's sustainability. These included numerical achievements against targets designed to reach 80% coverage over two years; quantitative expenditure outcomes including unit expenditure plus its primary drivers; and qualitative community perception of program quality and sustainability based on Likert scale. Outcome values at baseline were compared with those for year one of model implementation using bivariate linear regression, unpaired t-tests and Wilcoxon rank tests as appropriate. Across models, numerical target achievement ranged from 45-140%, with the mixed models performing best in both counties. Unit expenditures varied from approximately $57 in both countries at baseline to $44-$124 in year 1, with the lowest values in the mixed and static models. Mean key informant perception scores generally rose significantly from baseline to year 1, with a notable drop in the area of community engagement. Consistently low scores were in the aspects of domestic financing for service provision. Sustainability-focused circumcision service delivery models can successfully achieve target volumes at lower unit expenditures than existing models, but strategies for domestic financing remain a crucial challenge to address for long-term maintenance of the program.

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.

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Dataset Information

Prospective comparison of two models of integrating early infant male circumcision with maternal child health services in Kenya: The Mtoto Msafi Mbili Study.

Publications

Prospective comparison of two models of integrating early infant male circumcision with maternal child health services in Kenya: The Mtoto Msafi Mbili Study.

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