Busting contraception myths and misconceptions among youth in Kwale County, Kenya: results of a digital health randomised control trial

Objectives: The objective of this randomised controlled trial in Kenya was to assess the effect of delivering sexual and reproductive health (SRH) information via text message to young people on their ability to reject contraception-related myths and misconceptions. Design and setting: A three-arm, unblinded randomised controlled trial with a ratio of 1:1:1 in Kwale County, Kenya. Participants and interventions: A total of 740 youth aged 18–24 years were randomised. Intervention arm participants could access informational SRH text messages on-demand. Contact arm participants received once weekly texts instructing them to study on an SRH topic on their own. Control arm participants received standard care. The intervention period was 7 weeks. Primary outcome: We assessed change myths believed at baseline and endline using an index of 10 contraception- related myths. We assessed change across arms using difference of difference analysis. Results: Across arms, \u3c5% of participants did not have any formal education, \u3c10% were living alone, about 50% were single and \u3e80% had never given birth. Between baseline and endline, there was a statistically significant drop in the average absolute number of myths and misconceptions believed by intervention arm (11.1%, 95% CI 17.1% to 5.2%), contact arm (14.4%, 95% CI 20.5% to 8.4%) and control arm (11.3%, 95% CI 17.4% to 5.2%) participants. However, we observed no statistically significant difference in the magnitude of change across arms. Conclusions: We are unable to conclusively state that the text message intervention was better than text message ‘contact’ or no intervention at all. Digital health likely has potential for improving SRH-related outcomes when used as part of multifaceted interventions. Additional studies with physical and geographical separation of different arms is warranted

Accuracy of assessment of eligibility for early medical abortion by community health workers in Ethiopia, India and South Africa

Objective To assess the accuracy of assessment of eligibility for early medical abortion by community health workers using a simple checklist toolkit. Design Diagnostic accuracy study. Setting Ethiopia, India and South Africa. METHODS: Two hundred seventeen women in Ethiopia, 258 in India and 236 in South Africa were enrolled into the study. A checklist toolkit to determine eligibility for early medical abortion was validated by comparing results of clinician and community health worker assessment of eligibility using the checklist toolkit with the reference standard exam. RESULTS: Accuracy was over 90% and the negative likelihood ratio <0.1 at all three sites when used by clinician assessors. Positive likelihood ratios were 4.3 in Ethiopia, 5.8 in India and 6.3 in South Africa. When used by community health workers the overall accuracy of the toolkit was 92% in Ethiopia, 80% in India and 77% in South Africa negative likelihood ratios were 0.08 in Ethiopia, 0.25 in India and 0.22 in South Africa and positive likelihood ratios were 5.9 in Ethiopia and 2.0 in India and South Africa. CONCLUSION: The checklist toolkit, as used by clinicians, was excellent at ruling out participants who were not eligible, and moderately effective at ruling in participants who were eligible for medical abortion. Results were promising when used by community health workers particularly in Ethiopia where they had more prior experience with use of diagnostic aids and longer professional training. The checklist toolkit assessments resulted in some participants being wrongly assessed as eligible for medical abortion which is an area of concern. Further research is needed to streamline the components of the tool, explore optimal duration and content of training for community health workers, and test feasibility and acceptability

A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls

STUDY QUESTION Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN, SIZE, DURATION This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. PARTICIPANTS, SETTING, METHODS The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of ≥70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5), and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2), respectively. Bleeding disturbances, the most frequent reason for method discontinuation, were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group, 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1), respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P < 0.0001). In the observational comparison between IUD and implant users, the 3-year relative risk for pregnancy in IUD group compared with the combined implant group was 5.7 per 100 W-Y (95% CI 4.4-7.3) (P = 0.0003). The 3-year expulsion rate of the IUD was 17.8 per 100 W-Y (95% CI 14.5-21.9), while the discontinuation rate for bleeding disturbances was 8.5 (95% CI 6.7-10.9). Frequency of complaints of headache and dizziness was not significantly different between implant and IUD users (P = 0.16 and 0.77, respectively), acne and bleeding irregularities were more frequent among implant users (P < 0.0001), while heavy bleeding and lower abdominal pain occurred more often among IUD than implant users (P < 0.0001). LIMITATIONS, REASONS FOR CAUTION Few women were ≤19 years old or nulligravida, the proportion of implant users ≥70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS Findings of the study can inform policy makers and clinicians about choice of implant, but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTEREST(S) UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 200

Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men

CONTEXT: The development of a safe and effective reversible method of male contraception is still an unmet need. OBJECTIVE: Evaluation of suppression of spermatogenesis and contraceptive protection by coadministered im injections of progestogen and testosterone. DESIGN: Prospective multicentre study. SETTING: Ten study centers. PARTICIPANTS: Healthy men, aged 18-45 years, and their 18- to 38-year-old female partners, both without known fertility problems. INTERVENTION: Intramuscular injections of 200-mg norethisterone enanthate combined with 1000-mg testosterone undecanoate, administered every 8 weeks. MAIN OUTCOMES MEASURES: Suppression of spermatogenesis by ejaculate analysis, contraceptive protection by pregnancy rate. RESULTS: Of the 320 participants, 95.9 of 100 continuing users (95% confidence interval [CI], 92.8-97.9) suppressed to a sperm concentration less than or equal to 1 million/mL within 24 weeks (Kaplan-Meier method). During the efficacy phase of up to 56 weeks, 4 pregnancies occurred among the partners of the 266 male participants, with the rate of 1.57 per 100 continuing users (95% CI, 0.59-4.14). The cumulative reversibility of suppression of spermatogenesis after 52 weeks of recovery was 94.8 per 100 continuing users (95% CI, 91.5-97.1). The most common adverse events were acne, injection site pain, increased libido, and mood disorders. Following the recommendation of an external safety review committee the recruitment and hormone injections were terminated early. CONCLUSIONS: The study regimen led to near-complete and reversible suppression of spermatogenesis. The contraceptive efficacy was relatively good compared with other reversible methods available for men. The frequencies of mild to moderate mood disorders were relatively high

A 3-year Multicentre Randomized Controlled Trial Of Etonogestrel- And Levonorgestrel-releasing Contraceptive Implants, With Non-randomized Matched Copper-intrauterine Device Controls.

Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of ≥70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5), and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2), respectively. Bleeding disturbances, the most frequent reason for method discontinuation, were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group, 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1), respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P < 0.0001). In the observational comparison between IUD and implant users, the 3-year relative risk for pregnancy in IUD group compared with the combined implant group was 5.7 per 100 W-Y (95% CI 4.4-7.3) (P = 0.0003). The 3-year expulsion rate of the IUD was 17.8 per 100 W-Y (95% CI 14.5-21.9), while the discontinuation rate for bleeding disturbances was 8.5 (95% CI 6.7-10.9). Frequency of complaints of headache and dizziness was not significantly different between implant and IUD users (P = 0.16 and 0.77, respectively), acne and bleeding irregularities were more frequent among implant users (P < 0.0001), while heavy bleeding and lower abdominal pain occurred more often among IUD than implant users (P < 0.0001). Few women were ≤19 years old or nulligravida, the proportion of implant users ≥70 kg was <20% and <8% were obese. Findings of the study can inform policy makers and clinicians about choice of implant, but also about TCu380A IUD in relation to implants. UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 2003.302527-253

Adaptation and validation of social accountability measures in the context of contraceptive services in Ghana and Tanzania

Background: Changes in the values, attitudes, and interactions of both service users and health care providers are central to social accountability processes in reproductive health. However, there is little consensus on how best to measure these latent changes. This paper reports on the adaptation and validation of measures that capture these changes in Tanzania and Ghana. Methods: The CaPSAI theory of change determined the dimensions of the measure, and we adapted existing items for the survey items. Trained data collectors used a survey to collect data from 752 women in Tanzania and 750 women in Ghana attending contraceptive services. We used reliability analysis, exploratory, and confirmatory factor analysis to assess the validity and reliability of these measures in each country. Results: The measure has high construct validity and reliability in both countries. We identified several subscales in both countries, 10 subscales in Tanzania, and 11 subscales in Ghana. Many of the domains and items were shared across both settings. Conclusion: The study suggests that the multi-dimensional scales have high construct validity and reliability in both countries. Though there were differences in the two country contexts and in items and scales, there was convergence in the analysis that suggests that this measure may be relevant in different settings and should be validated in new settings

Protocol of an open, three-arm, individually randomized trial assessing the effect of delivering sexual and reproductive health information to young people (aged 13–24) in Kenya and Peru via mobile phones: adolescent/youth reproductive mobile access and delivery initiative for love and life outcomes (ARMADILLO) study stage 2

Resumen Antecedentes Las personas jóvenes se enfrentan a desafíos únicos en cuanto a acceso a información y apoyo en temas de salud sexual y reproductiva (SSR). Debido a su elevada penetración y acceso, los teléfonos celulares brindan un nuevo canal para acceder a los jóvenes. Sin embargo, existe poca evidencia sobre el impacto de las intervenciones digitales en la mejora de los resultados de salud. La investigación ARMADILLO (Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes en inglés y Uso de celulares para mejorar resultados de amor y vida en adolescentes y jóvenes en español) evaluará el efecto de una intervención que brinda información sobre SSR a jóvenes mediante mensajes de texto a sus celulares en Kenia y Perú. Este protocolo detalla un ensayo abierto de tres brazos aleatorizado a nivel individual que dura siete semanas y evalúa el efecto de la intervención ARMADILLO para disipar los mitos e ideas equivocadas relacionadas a los métodos anticonceptivos. Un objetivo secundario es determinar si los jóvenes que tienen acceso a información sobre SSR vía mensaje de texto pueden retener esa información de manera precisa. Métodos Posterior a una enumeración de hogares, una persona joven por cada hogar será seleccionada al azar para ser participante y será randomizada por computadora en uno de los tres brazos. Los participantes del brazo intervención recibirán acceso a los contenidos de ARMADILLO, los participantes del brazo control no recibirán ninguna información, y los participantes del ‘brazo 3’ variarán según la sede: en Kenia, serán alertados sobre diversos dominios de SSR y animados a aprender más por su cuenta; en Perú, recibirán contenidos claves de cada dominio con la opción de aprender más si desean. Los participantes completarán encuestas de opción múltiple administradas por encuestadores durante la línea basal (antes de ser randomizados), al final de la intervención (después de la semana 7), y ocho semanas después de terminar la intervención. Discusión Parte del compromiso de los Objetivos de Desarrollo Sostenible hacia garantizar una vida sana y promover el bienestar para todos en todas las edades incluye un compromiso a ‘garantizar el acceso universal a los servicios de salud sexual y reproductiva, incluidos los de planificación de la familia, información y educación’. Si se prueba su efectividad, intervenciones como ARMADILLO podrían tender un puente sobre una brecha importante hacia el logro del acceso universal a información y educación en SSR para un grupo que es difícil de alcanzar de otra manera. Registro del Ensayo Este ensayo se registró de manera retrospectiva con el Registro ISRCTN y fue asignado el número de registro ISRCTN85156148 el 29 de mayo, 2018

Impact of community and provider-driven social accountability interventions on contraceptive uptake in Ghana and Tanzania

Background: Social accountability, which is defined as a collective process for holding duty bearers and service providers to account for their actions, has shown positive outcomes in addressing the interrelated barriers to quality sexual and reproductive health services. The Community and Provider driven Social Accountability Intervention (CaPSAI) Project contributes to the evidence on the effects of social accountability processes in the context of a family planning and contraceptive programme. Methods: A quasi-experimental study utilizing an interrupted time series design with a control group (ITS-CG) was conducted to determine the actual number of new users of contraception amongst women 15–49 years old in eight intervention and eight control facilities per country in Ghana and Tanzania. A standardized facility audit questionnaire was used to collect facility data and completed every year in both intervention and control groups in each country from 2018–2020. Results: In Ghana, the two-segmented Poisson Generalized Estimating Equation (GEE) model demonstrated no statistically significant difference at post-intervention, between the intervention and control facilities, in the level of uptake of contraceptives (excess level) (p-value = 0.07) or in the rate of change (excess rate) in uptake (p-value = 0.07) after adjusting for baseline differences. Similarly, in Tanzania, there was no statistical difference between intervention and control facilities, in the level of uptake of contraceptives (excess level) (p-value = 0.20), with the rate of change in uptake (p-value = 0.05) after adjusting for the baseline differences. There was no statistical difference in the level of or rate of change in uptake in the two groups in a sensitivity analysis excluding new users recruited in outreach activities in Tanzania. Conclusions: The CAPSAI project intervention did not result in a statistically significant increase in uptake of contraceptives as measured by the number of or increase in new users. In evaluating the impact of the intervention on the intermediate outcomes such as self-efficacy among service users, trust and countervailing power among social groups/networks, and responsiveness of service providers, cases of change and process evaluation should be considered. Trial registration: The CaPSAI Project has been registered at the Australian New Zealand Clinical Trials Registry (ACTRN12619000378123, 11/03/2019)