Safety, Quality, and Acceptability of Contraceptive Implant Provision by Community Health Extension Workers versus Nurses and Midwives in Two States in Nigeria.

Task sharing is a strategy with potential to increase access to effective modern contraceptive methods. This study examines whether community health extension workers (CHEWs) can insert contraceptive implants to the same safety and quality standards as nurse/midwives. We analyze data from 7,691 clients of CHEWs and nurse/midwives who participated in a noninferiority study conducted in Kaduna and Ondo States, Nigeria. Adverse events (AEs) following implant insertions were compared. On the day of insertion AEs were similar among CHEW and nurse/midwife clients-0.5 percent and 0.4 percent, adjusted odds ratio (aOR) 0.92 (95 percent CI 0.38-2.23)-but noninferiority could not be established. At follow-up 6.6 percent of CHEW clients and 2.1 percent of nurse/midwife clients experienced AEs. There was strong evidence of effect modification by State. In the final adjusted model, odds of AEs for CHEW clients in Kaduna was 3.34 (95 percent CI 1.53-7.33) compared to nurse/midwife clients, and 0.72 (95 percent CI 0.19-2.72]) in Ondo. Noninferiority could not be established in either State. Implant expulsions were higher among CHEW clients (142/2987) compared to nurse/midwives (40/3517). Results show the feasibility of training CHEWs to deliver implants in remote rural settings but attention must be given to provider selection, training, supervision, and follow-up to ensure safety and quality of provision.

Impact of integration of sexual and reproductive health services on consultation duration times: results from the Integra Initiative.

The lack of human resources is a key challenge in scaling up of HIV services in Africa's health care system. Integrating HIV services could potentially increase their effectiveness and optimize the use of limited resources and clinical staff time. We examined the impact of integration of provider initiated HIV counselling and testing (PITC) and family planning (FP counselling and FP provision) services on duration of consultation to assess the impact of PITC and FP integration on staff workload. This study was conducted in 24 health facilities in Kenya under the Integra Initiative, a non-randomized, pre/post intervention trial to evaluate the impact of integrated HIV and sexual and reproductive health services on health and service outcomes. We compared the time spent providing PITC-only services, FP-only services and integrated PITC/FP services. We used log-linear regression to assess the impact of plausible determinants on the duration of clients' consultation times. Median consultation duration times were highest for PITC-only services (30 min), followed by integrated services (10 min) and FP-only services (8 min). Times for PITC-only and FP-only services were 69.7% higher (95% Confidence Intervals (CIs) 35.8-112.0) and 43.9% lower (95% CIs -55.4 to - 29.6) than times spent on these services when delivered as an integrated service, respectively. The reduction in consultation times with integration suggests a potential reduction in workload. The higher consultation time for PITC-only could be because more pre- and post-counselling is provided at these stand-alone services. In integrated PITC/FP services, the duration of the visit fell below that required by HIV testing guidelines, and service mix between counselling and testing substantially changed. Integration of HIV with FP services may compromise the quality of services delivered and care must be taken to clearly specify and monitor appropriate consultation duration times and procedures during the process of integrating HIV and FP services.

Integration of HIV and maternal healthcare in a high HIV-prevalence setting: analysis of client flow data over time in Swaziland.

OBJECTIVE: Maternal and child health (MCH) care may provide an entry point for HIV services in high HIV-prevalence settings. Our objective was to assess integration of HIV with MCH services in public sector facilities in Swaziland. DESIGN: In 2009, 2010 and 2012, client flow assessments (CFAs) were conducted over 5 days in the MCH units of eight government facilities, purposively selected as intervention or comparison sites. PARTICIPANTS: 8263 MCH visits with female clients were tracked: 3261 in 2009, 2086 in 2010 and 2916 in 2012. INTERVENTION: Activities and resources to strengthen integration of HIV services into postnatal care (PNC), 2009-2010. MAIN OUTCOME MEASURES: The proportion of all visits in which an HIV/sexually transmitted infection (STI) testing, counselling or treatment was received together with an MCH service; the proportion of all visits in which a client receives HIV counselling. RESULTS: Across facilities, the proportion of visits in which HIV/STI and MCH services were received varied considerably, for example, from 9% to 49% in 2009. HIV/STI services were integrated most frequently with child health (CH), antenatal care (ANC) and family planning (FP)-the most common reasons for women's attendance-and least often with PNC and cervical screening (CS). There was no meaningful difference in integration over time by design group and considerable heterogeneity across facilities. Receipt of integrated services increased in one intervention and two comparison facilities, where HIV counselling also rose, and fell in one intervention and two comparison facilities. CONCLUSIONS: Provision of HIV/STI services with MCH care occurred at all facilities, yet relatively few women receive integrated services. Increases in integration were driven by increases in HIV counselling, while sharp declines in some facilities indicate that integration is difficult to sustain. Opportunities for intensifying HIV integration lie with ANC, CH and FP, while HIV-PNC integration will remain limited until more women attend PNC. TRIAL REGISTRATION NUMBER: Current Controlled Trials NCT01694862.

Effect of vitamin A supplementation on cause-specific mortality in women of reproductive age in Ghana: a secondary analysis from the ObaapaVitA trial.

OBJECTIVE: To determine the effect of weekly low-dose vitamin A supplementation on cause-specific mortality in women of reproductive age in Ghana. METHODS: A cluster-randomized, triple-blind, placebo-controlled trial was conducted in seven districts of the Brong Ahafo region of Ghana. Women aged 15-45 years who were capable of giving informed consent and intended to live in the trial area for at least 3 months were enrolled and randomly assigned, according to their cluster of residence, to receive oral vitamin A (7500 µg) or placebo once a week. Randomization was blocked, with two clusters in each fieldwork area allocated to vitamin A and two to placebo. Every 4 weeks, fieldworkers distributed capsules and collected data during home visits. Verbal autopsies were conducted by field supervisors and reviewed by physicians, who assigned a cause of death. Cause-specific mortality rates in both arms were compared by means of random-effects Poisson regression models to allow for the cluster randomization. Analysis was by intention-to-treat, based on cluster of residence, with women eligible for inclusion once they had consistently received the supplement or placebo capsules for 6 months. FINDINGS: The analysis was based on 581 870 woman-years and 2624 deaths. Cause-specific mortality rates were found to be similar in the two study arms. CONCLUSION: Low-dose vitamin A supplements administered weekly are of no benefit in programmes to reduce mortality in women of childbearing age.

Résumé OBJECTIF: Déterminer l'effet de la supplémentation hebdomadaire en vitamine A à faible dose sur la mortalité spécifique des femmes en âge de procréer au Ghana. MÉTHODES: Une étude randomisée, en triple aveugle, contrôlée contre placebo, a été menée dans sept districts de la région de Brong Ahafo au Ghana. Les femmes âgées de 15 à 45 ans, capables de donner un consentement éclairé et amenées à vivre dans la région de l'étude pendant au moins 3 mois, ont été incluses et il a été déterminé qu'elles recevraient une fois par semaine, au hasard selon leur groupe de résidence, de la vitamine A par voie orale (7 500 µg) ou un placebo. La randomisation a été fixée par deux groupes dans chaque zone recevant la vitamine A et deux groupes recevant le placebo. Toutes les 4 semaines, les agents de terrain distribuaient les capsules et recueillaient les données lors de visites à domicile. Des autopsies orales ont été effectuées par les superviseurs sur le terrain et analysées par des médecins, qui déterminaient la cause du décès. Les taux de mortalité spécifique dans les deux groupes ont été comparés à l'aide d'une régression de Poisson pour valider la randomisation des groupes. L'analyse, basée sur l'intention de traiter, était basée sur le groupe de résidence, pour des femmes éligibles à l'étude ayant reçu les capsules de supplément ou de placebo de manière constante pendant 6 mois. RÉSULTATS: L'analyse s'est basée sur 581 870 années-femmes et 2624 décès. Les taux de mortalité spécifique ont été jugés similaires dans les deux groupes de l'étude. CONCLUSION: Les suppléments en vitamine A à faible dose administrés hebdomadairement ne sont d'aucune utilité dans les programmes visant à réduire la mortalité chez les femmes en âge de procréer.

Resumen OBJETIVO: Determinar el efecto de la administración semanal de dosis bajas de vitamina A en la mortalidad por causas específicas de mujeres en edad reproductiva en Ghana. MÉTODOS: Se realizó un ensayo aleatorio de grupos, triple ciego y controlado por placebo en siete distritos de la región de Brong Ahafo, en Ghana. Se inscribieron mujeres de entre 15 y 45 años de edad capaces de dar su consentimiento informado y que tuvieran previsto vivir en el área de ensayo durante al menos tres meses. De acuerdo con el grupo de residencia al que habían sido asignadas de forma aleatoria, recibieron semanalmente vitamina A por vía oral (7500 µg) o placebo. La distribución aleatoria se limitó en cada área de trabajo a dos grupos a los que se les administró vitamina A y dos grupos que recibieron placebo. Cada cuatro semanas, los investigadores de campo distribuyeron cápsulas y recogieron datos durante las visitas a los hogares. Las autopsias verbales realizadas por los supervisores de campo fueron revisadas por médicos, quienes determinaron la causa de la muerte. Se compararon las tasas de mortalidad por causas específicas de ambos brazos mediante los modelos de regresión de Poisson con efectos aleatorios para facilitar la distribución aleatoria de los grupos. El análisis fue por intención de tratar, según el grupo de residencia y con mujeres que cumplieron las condiciones de inclusión una vez habían recibido de forma constante las cápsulas de suplemento o placebo durante seis meses. RESULTADOS: El análisis se basó en 581 870 años-mujer y 2624 muertes. Se descubrió que las tasas de mortalidad por causas específicas fueron similares en ambos brazos del estudio. CONCLUSIÓN: Los suplementos de dosis bajas de vitamina A administrados semanalmente no presentan ninguna ventaja en los programas para reducir la mortalidad de las mujeres en edad reproductiva.

Effect of vitamin A supplementation in women of reproductive age on cause-specific early and late infant mortality in rural Ghana: ObaapaVitA double-blind, cluster-randomised, placebo-controlled trial.

Objectives To assess the effect of vitamin A supplementation in women of reproductive age in Ghana on cause- and age-specific infant mortality. In addition, because of recently published studies from Guinea Bissau, effects on infant mortality by sex and season were assessed. Design Double-blind, cluster-randomised, placebo-controlled trial. Setting 7 contiguous districts in the Brong Ahafo region of Ghana. Participants All women of reproductive age (15-45 years) resident in the study area randomised by cluster of residence. All live born infants from 1 June 2003 to 30 September 2008 followed up through 4-weekly home visits. Intervention Weekly low-dose (25 000 IU) vitamin A. Main outcome measures Early infant mortality (1-5 months); late infant mortality (6-11 months); infection-specific infant mortality (0-11 months). Results 1086 clusters, 62 662 live births, 52 574 infant-years and 3268 deaths yielded HRs (95% CIs) comparing weekly vitamin A with placebo: 1.04 (0.88 to 1.05) early infant mortality; 0.99 (0.84 to 1.18) late infant mortality; 1.03 (0.92 to 1.16) infection-specific infant mortality. There was no evidence of modification of the effect of vitamin A supplementation on infant mortality by sex (Wald statistic =0.07, p=0.80) or season (Wald statistic =0.03, p=0.86). Conclusions This is the largest analysis of cause of infant deaths from Africa to date. Weekly vitamin A supplementation in women of reproductive age has no beneficial or deleterious effect on the causes of infant death to age 6 or 12 months in rural Ghana. Trial registration number http://ClinicalTrials.gov: NCT00211341.

Improving hygiene in home deliveries in rural Ghana: how to build on current attitudes and practices.

INTRODUCTION: Clean delivery of newborns is a key intervention for reducing infection-related neonatal mortality. Understanding local practices and beliefs is important for designing appropriate interventions. There are few data from Africa. This study explored delivery practices in Ghana to identify behaviors for intervention and to determine behavioral influencers. METHODS: Data on the prevalence of clean delivery behaviors, collected through a demographic surveillance system, were analyzed for 2631 women who delivered at home within a 1-year period. Qualitative data on delivery practices were collected through birth narratives, in-depth interviews, and focus groups with recently delivered/pregnant women, traditional birth attendants, grandmothers, and husbands. RESULTS: Most women delivered on a covered surface (79%), had birth attendants who washed their hands (79%), cut the cord with a new blade (98%), and tied it with a new thread (90%). Eight percent of families practiced dry cord care. Families understood the importance of a clean delivery surface and many birth attendants knew the importance of hand-washing. Delivering on an uncovered surface was linked to impromptu deliveries and a belief that a swept floor is clean. Not washing hands was linked to rushing to help the woman, not being provided with soap, forgetfulness, and a belief among some that the babies are born dirty. The frequent application of products to the cord was nearly universal and respondents believed that applying nothing to the cord would have serious negative consequences. CONCLUSIONS: Delivery surfaces, hand-washing, and cord cutting and tying appear appropriate for the majority of women. Changing cord care practices is likely to be difficult unless replacement products are provided.

Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial.

BACKGROUND: A previous trial in Nepal showed that supplementation with vitamin A or its precursor (betacarotene) in women of reproductive age reduced pregnancy-related mortality by 44% (95% CI 16-63). We assessed the effect of vitamin A supplementation in women in Ghana. METHODS: ObaapaVitA was a cluster-randomised, double-blind, placebo-controlled trial undertaken in seven districts in Brong Ahafo Region in Ghana. The trial area was divided into 1086 small geographical clusters of compounds with fieldwork areas consisting of four contiguous clusters. All women of reproductive age (15-45 years) who gave informed consent and who planned to remain in the area for at least 3 months were recruited. Participants were randomly assigned by cluster of residence to receive a vitamin A supplement (25 000 IU retinol equivalents) or placebo capsule orally once every week. Randomisation was blocked and based on an independent, computer-generated list of numbers, with two clusters in each fieldwork area allocated to vitamin A supplementation and two to placebo. Capsules were distributed during home visits undertaken every 4 weeks, when data were gathered on pregnancies, births, and deaths. Primary outcomes were pregnancy-related mortality and all-cause female mortality. Cause of death was established by verbal post mortems. Analysis was by intention to treat (ITT) with random-effects regression to account for the cluster-randomised design. Adverse events were synonymous with the trial outcomes. This trial is registered with ClinicalTrials.gov, number NCT00211341. FINDINGS: 544 clusters (104 484 women) were randomly assigned to vitamin A supplementation and 542 clusters (103 297 women) were assigned to placebo. The main reason for participant drop out was migration out of the study area. In the ITT analysis, there were 39 601 pregnancies and 138 pregnancy-related deaths in the vitamin A supplementation group (348 deaths per 100 000 pregnancies) compared with 39 234 pregnancies and 148 pregnancy-related deaths in the placebo group (377 per 100 000 pregnancies); adjusted odds ratio 0.92, 95% CI 0.73-1.17; p=0.51. 1326 women died in 292 560 woman-years in the vitamin A supplementation group (453 deaths per 100 000 years) compared with 1298 deaths in 289 310 woman-years in the placebo group (449 per 100 000 years); adjusted rate ratio 1.01, 0.93-1.09; p=0.85. INTERPRETATION: The body of evidence, although limited, does not support inclusion of vitamin A supplementation for women in either safe motherhood or child survival strategies. FUNDING: UK Department for International Development, and USAID.