Summary Background Observational and laboratory studies suggest that some hormonal contraceptive methods, particularly intramuscular depot medroxyprogesterone acetate (DMPA-IM), might increase women's susceptibility to HIV acquisition. We aimed to compare DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant among African women seeking effective contraception and living in areas of high HIV incidence. Methods We did a randomised, multicentre, open-label trial across 12 research sites in eSwatini, Kenya, South Africa, and Zambia. We included HIV-seronegative women aged 16–35 years who were seeking effective contraception, had no medical contraindications to the trial contraceptive methods, agreed to use the assigned method for 18 months, and reported not using injectable, intrauterine, or implantable contraception for the previous 6 months. Participants were randomly assigned (1:1:1) to receive an injection of 150 mg/mL DMPA-IM every 3 months, a copper IUD, or a LNG implant with random block sizes between 15 and 30, stratified by site. Participants were assigned using an online randomisation system, which was accessed for each randomisation by study staff at each site. The primary endpoint was incident HIV infection in the modified intention-to-treat population, including all randomised participants who were HIV negative at enrolment and who contributed at least one HIV test. The primary safety endpoint was any serious adverse event or any adverse event resulting in method discontinuation, until the trial exit visit at 18 months and was assessed in all enrolled and randomly assigned women. This study is registered with ClinicalTrials.gov , number NCT02550067 . Findings Between Dec 14, 2015, and Sept 12, 2017, 7830 women were enrolled and 7829 were randomly assigned to the DMPA-IM group (n=2609), the copper IUD group (n=2607), or the LNG implant group (n=2613). 7715 (99%) participants were included in the modified intention-to-treat population (2556 in the DMPA-IM group, 2571 in the copper IUD group, and 2588 in the LNG implant group), and women used their assigned method for 9567 (92%) of 10 409 woman-years of follow-up time. 397 HIV infections occurred (incidence 3·81 per 100 woman-years [95% CI 3·45–4·21]): 143 (36%; 4·19 per 100 woman-years [3·54–4·94]) in the DMPA-IM group, 138 (35%: 3·94 per 100 woman-years [3·31–4·66]) in the copper IUD group, and 116 (29%; 3·31 per 100 woman-years [2·74–3·98]) in the LNG implant group. In the modified intention-to-treat analysis, the hazard ratios for HIV acquisition were 1·04 (96% CI 0·82–1·33, p=0·72) for DMPA-IM compared with copper IUD, 1·23 (0·95–1·59, p=0·097) for DMPA-IM compared with LNG implant, and 1·18 (0·91–1·53, p=0·19) for copper IUD compared with LNG implant. 12 women died during the study: six in the DMPA-IM group, five in the copper IUD group, and one in the LNG implant group. Serious adverse...
Background South Africa faces numerous reproductive challenges that include high rates of unplanned and adolescent pregnancies. The uptake and utilization of family planning services and modern contraception methods depend on numerous factors. The male partner plays a key role in reproductive health but data on this topic are outdated or have a predominant HIV prevention focus. The purpose of this paper is to explore the influence of male partners on family planning and contraceptive (FP/C) uptake and use within the contemporary South African setting, and to identify further areas of exploration. Methods This qualitative study was conducted in a community and healthcare provision setting in the eThekwini District in KwaZulu-Natal province, South Africa. Data were collected from twelve community-based focus group discussions ( n = 103), two healthcare providers focus group discussions ( n = 16), and eight key informant individual in-depth interviews. Following a constructionist paradigm and using the health utilization behaviour model, data were analysed using thematic analysis, allowing a robust and holistic exploration of the data. Results The data from this study revealed the complex and evolving role that male partners play in FP/C uptake and use within this setting. Key themes from the data elucidated the dual nature of male involvement in FP/C use. Culturally influenced gender dynamics and adequate understanding of FP/C information were highlighted as key factors that influenced male attitudes and perceptions about contraceptive use, whether positively or negatively. Male opposition was attributed to limited understanding; misunderstandings about side-effects; male dominance in relationships; and physical abuse. These factors contributed to covert or discontinued use by female partners. Pathways identified through which male partners positively influenced FP/C uptake and access include: social support, adequate information, and shared responsibility. Conclusions Understanding the role that male partners play in FP/C uptake and use is important in preventing unintended pregnancies and improving family planning policy and service delivery programmes. By identifying the barriers that male partners present, appropriate strategies can be implemented. Equally important is identifying how male partners facilitate and promote adherence and use, and how these positive strategies can be incorporated into policy to improve the uptake and use of FP/C.
Objective and design:Some studies suggest that specific hormonal contraceptive methods [particularly depot medroxyprogesterone acetate (DMPA)] may increase women's HIV acquisition risk. We updated a systematic review to incorporate recent epidemiological data.Methods:We searched for articles published between 15 January 2014 and 15 January 2016 and hand-searched reference lists. We identified longitudinal studies comparing users of a specific hormonal contraceptive method against either nonusers of hormonal contraception or users of another specific hormonal contraceptive method. We added newly identified studies to those in the previous review, assessed study quality, created forest plots to display results, and conducted a meta-analysis for data on DMPA versus non-use of hormonal contraception.Results:We identified 10 new reports of which five were considered ‘unlikely to inform the primary question’. We focus on the other five reports, along with nine from the previous review, which were considered ‘informative but with important limitations’. The preponderance of data for oral contraceptive pills, injectable norethisterone enanthate, and levonorgestrel implants do not suggest an association with HIV acquisition, though data for implants are limited. The new, higher quality studies on DMPA (or nondisaggregated injectables), which had mixed results in terms of statistical significance, had hazard ratios between 1.2 and 1.7, consistent with our meta-analytic estimate for all higher quality studies of hazard ratio 1.4.Conclusion:Although confounding in these observational data cannot be excluded, new information increases concerns about DMPA and HIV acquisition risk in women. If the association is causal, the magnitude of effect is likely hazard ratio 1.5 or less. Data for other hormonal contraceptive methods, including norethisterone enanthate, are largely reassuring.
Whether use of various types of hormonal contraception (HC) affect risk of HIV acquisition is a critical question for women's health. For this systematic review, we identified 22 studies published by January 15, 2014 which met inclusion criteria; we classified thirteen studies as having severe methodological limitations, and nine studies as "informative but with important limitations". Overall, data do not support an association between use of oral contraceptives and increased risk of HIV acquisition. Uncertainty persists regarding whether an association exists between depot-medroxyprogesterone acetate (DMPA) use and risk of HIV acquisition. Most studies suggested no significantly increased HIV risk with norethisterone enanthate (NET-EN) use, but when assessed in the same study, point estimates for NET-EN tended to be larger than for DMPA, though 95% confidence intervals overlapped substantially. No data have suggested significantly increased risk of HIV acquisition with use of implants, though data were limited. No data are available on the relationship between use of contraceptive patches, rings, or hormonal intrauterine devices and risk of HIV acquisition. Women choosing progestin-only injectable contraceptives such as DMPA or NET-EN should be informed of the current uncertainty regarding whether use of these methods increases risk of HIV acquisition, and like all women at risk of HIV, should be empowered to access and use condoms and other HIV preventative measures. Programs, practitioners, and women urgently need guidance on how to maximize health with respect to avoiding both unintended pregnancy and HIV given inconclusive or limited data for certain HC methods.
BackgroundUnmet need for contraception results in several health challenges such as unintended pregnancies, unwanted births and unsafe abortions. Most interventions have been unable to successfully address this unmet need due to various community and health system level factors. Identifying these inhibiting and enabling factors prior to implementation of interventions forms the basis for planning efforts to increase met needs. This qualitative study was part of the formative phase of a larger research project that aimed to develop an intervention to increase met needs for contraception through community and health system participation. The specific study component reported here explores barriers and enablers to family planning and contraceptive services provision and utilisation at community and health systems levels.MethodsTwelve focus group discussions were conducted with community members (n = 114) and two with healthcare providers (n = 19). Ten in-depth interviews were held with key stakeholders. The study was conducted in Kabwe district, Zambia. Interviews/discussions were translated and transcribed verbatim. Data were coded and organised using NVivo 10 (QSR international), and were analysed using thematic analysis.ResultsHealth systems barriers include long distances to healthcare facilities, stock-outs of preferred methods, lack of policies facilitating contraceptive provision in schools, and undesirable provider attitudes. Community level barriers comprise women’s experience with contraceptive side effects, myths, rumours and misconceptions, societal stigma, and negative traditional and religious beliefs. On the other hand, health systems enablers consist of political will from government to expand contraceptive services access, integration of contraceptive services, provision of couples counselling, and availability of personnel to offer basic methods mix. Functional community health system structures, community desire to delay pregnancy, and knowledge of contraceptive services are enablers at a community level.ConclusionsThese study findings highlight key community and health systems factors that should be considered by policy, program planners and implementers in the design and implementation of family planning and contraceptive services programmes, to ensure sustained uptake and increased met needs for contraceptive methods and services.Electronic supplementary materialThe online version of this article (10.1186/s12913-018-3136-4) contains supplementary material, which is available to authorized users.
There is a growing body of research on the role of social accountability in bringing about more accessible and better-quality healthcare. Here, we refer to social accountability as “ citizens’ efforts at ongoing meaningful collective engagement with public institutions for accountability in the provision of public goods ” (Joshi, World Dev 99:160–172, 2017). These processes have multiple interrelated components and sub-processes and engage a range of actors in community-driven, often unpredictable and context-dependent actions, which pose many methodological challenges for researchers. In June 2017, scientists and implementers working in this area came together to share experiences, discuss approaches, identify research gaps and consider directions for future studies. This paper shares learnings from this discussion. In particular, participants considered (1) how best to define and measure the complex processual nature of social accountability; (2) the study of social accountability as an inherently political process; and (3) the challenges of generalising unpredictable, community-driven and context-dependent processes. Key among a range of consensus areas was the need for researchers to capture a broader range of outcomes and better understand the nuances of implementation processes in order to effectively test theories and assumptions. Furthermore, power relationships are inherent in social accountability and the research process itself. In presenting details on these deliberations, we hope to prompt a wider discussion on the study of social accountability in health programming.
As efforts to address unmet need for family planning and contraception (FP/C) accelerate, voluntary use, informed choice and quality must remain at the fore. Active involvement of affected populations has been recognized as one of the key principles in ensuring human rights in the provision of FP/C and in improving quality of care. However, community participation continues to be inadequately addressed in large-scale FP/C programmes. Community and healthcare providers’ unequal relationship can be a barrier to successful participation. This scoping review identifies participatory approaches involving both community and healthcare providers for FP/C services and analyzes relevant evidence. The detailed analysis of 25 articles provided information on 28 specific programmes and identified three types of approaches for community and healthcare provider participation in FP/C programmes. The three approaches were: (i) establishment of new groups either health committees to link the health service providers and users or implementation teams to conduct specific activities to improve or extend available health services, (ii) identification of and collaboration with existing community structures to optimise use of health services and (iii) operationalization of tools to facilitate community and healthcare provider collaboration for quality improvement. Integration of community and healthcare provider participation in FP/C provision were conducted through FP/C-only programmes, FP/C-focused programmes and/or as part of a health service package. The rationales behind the interventions varied and may be multiple. Examples include researcher-, NGO- or health service-initiated programmes with clear objectives of improving FP/C service provision or increasing demand for services; facilitating the involvement of community members or service users and, in some cases, may combine socio-economic development and increasing self-reliance or control over sexual and reproductive health. Although a number of studies reported increase in FP/C knowledge and uptake, the lack of robust monitoring and evaluation mechanisms and quantitative and comparable data resulted in difficulties in generating clear recommendations. It is imperative that programmes are systematically designed, evaluated and reported.
Background Community dialogues have been widely used as a method for community engagement and participation to cover a broad range of areas. However, there has been limited documentation and evaluation of the process, particularly as a method towards achieving family planning and contraception (FP/C) programme goals. As part of the development of an intervention package aimed at increasing community and health care provider (HCP) participation in the provision of FP/C, feasibility testing of the intervention approach (a community dialogue between communities and health facilities) was carried out. Our findings offer a systematic description and evaluation of the community dialogue process, with key recommendations towards future implementation. Methods The dialogue was evaluated in three ways: 1) through participant observation during the community dialogue, 2) via a standardised feasibility testing tick-list for all observers of the dialogue, and 3) through three focus group discussions (FGDs) consisting of different groups of stakeholders who participated in the community dialogue. In total, 28 community members, HCPs, and key stakeholders attended the community dialogue (22 females, 6 males). Twenty-seven of the community dialogue participants participated in one of 3 FGDs held after the dialogue. Six evaluators assessed feasibility of the dialogue process. Results There was good attendance, representation and participation amongst community and provider sectors based on the participant observations using the standardized feasibility check-list. The community dialogue process received positive feedback in the FGDs and was demonstrated to be feasible and acceptable. Key factors contributing to the success of the community dialogue included a skilled facilitator, good representation of participants, establishing ground rules, good timekeeping, and using a Theory of Change to facilitate goal identification and dialogue. Issues to consider are the underlying power differentials related to age, profession and gender which caused initial feelings of anxiety amongst some participants. Conclusions Our formative findings offer a systematic description and evaluation of a community dialogue process with key recommendations that may be considered when constituting similar community dialogues in the future.
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