Rights based approaches to sexual and reproductive health in low and middle-income countries: A systematic review

Introduction The Sustainable Development Goals, which are grounded in human rights, involve empowering women and girls and ensuring that everyone can access sexual and reproductive health and rights (Goal 5). This is the first systematic review reporting interventions involving rights-based approaches for sexual and reproductive health issues including gender-based violence, maternity, HIV and sexually transmitted infections in low and middle-income countries. Aims To describe the evidence on rights-based approaches to sexual and reproductive health in low and middle-income countries. Methods EMBASE, MEDLINE and Web of Science were searched until 9/1/2020. Inclusion criteria were: Study design: any interventional study. Population: females aged over 15 living in low and middle-income countries. Intervention: a “rights-based approach” (defined by the author) and/or interventions that the author explicitly stated related to "rights". Comparator: clusters in which no intervention or fewer components of an intervention were in place, or individuals not exposed to interventions, or exposed to fewer intervention components. Outcome: Sexual and reproductive health related outcomes. A narrative synthesis of included studies was undertaken, and outcomes mapped to identify evidence gaps. The systematic review protocol was registered on PROSPERO (CRD42019158950). Results Database searching identified 17,212 records, and 13,404 studies remained after de-duplication. Twenty-four studies were included after title and abstract, full-text and reference-list screening by two authors independently. Rights-based interventions were effective for some included outcomes, but evidence was of poor quality. Testing uptake for HIV and/or other sexually transmitted infections, condom use, and awareness of rights improved with intervention, but all relevant studies were at high, critical or serious risk of bias. No study included gender-based violence outcomes. Conclusion Considerable risk of bias in all studies means results must be interpreted with caution. High-quality controlled studies are needed urgently in this area.


Introduction
The Sustainable Development Goals, which are grounded in human rights, involve empowering women and girls and ensuring that everyone can access sexual and reproductive health and rights (Goal 5). This is the first systematic review reporting interventions involving rights-based approaches for sexual and reproductive health issues including gender-based violence, maternity, HIV and sexually transmitted infections in low and middle-income countries.

Aims
To describe the evidence on rights-based approaches to sexual and reproductive health in low and middle-income countries.

Methods
EMBASE, MEDLINE and Web of Science were searched until 9/1/2020. Inclusion criteria were: • Study design: any interventional study.
• Population: females aged over 15 living in low and middle-income countries.
• Intervention: a "rights-based approach" (defined by the author) and/or interventions that the author explicitly stated related to "rights".
• Comparator: clusters in which no intervention or fewer components of an intervention were in place, or individuals not exposed to interventions, or exposed to fewer intervention components.
• Outcome: Sexual and reproductive health related outcomes.
A narrative synthesis of included studies was undertaken, and outcomes mapped to identify evidence gaps.

Introduction
An estimated 810 women died every day in 2017 from pregnancy or childbirth-related preventable causes; 94% of these deaths were in low and middle-income countries (LMICs) [1]. But it is not just childbirth where women suffer poor sexual and reproductive health outcomes: women and girls make up nearly three quarters of new infections of HIV worldwide amongst those aged 10-19 [2]. Gender-based violence increases the risk of HIV [3], and in some areas, up to 45% of girls' first sexual encounter was forced [4]. Between 2010 and 2018, there was a reduction in new HIV infections in females between 15-24 years but despite this, there are approximately 6000 new infections per week worldwide [5]. The Joint United Nations Programme on HIV/AIDS (UNAIDS) recommends that to combat HIV we must advance gender equality and human rights [6]. By 2030, the Sustainable Development Goals (SDG), which are grounded in human rights, include empowering women and girls (Goal 5) and ensuring "universal access to sexual and reproductive health and reproductive rights" (Section 5.6) [7]. The United Nations Population Fund (UNFPA) define good sexual and reproductive health as "a state of complete physical, mental and social well-being in all matters relating to the reproductive system. It implies that people are able to have a satisfying and safe sex life, the capability to reproduce, and the freedom to decide if, when, and how often to do so" [8].
The International Covenant on Economic, Social and Cultural Rights, which opened in 1966 and came into force in 1976, requires States which are under the Charter of the United Nations to promote human rights [9]. The UN Common Understanding on a Human-Rights-Based Approach to Development Cooperation outlines what a human rights based approach should entail (as a minimum) [10]. Essential elements include accounting for the recommendations of international human rights bodies; monitoring and evaluating outcomes and processes following human rights principles and standards; identifying barriers and building capacity for individuals (rights holders) to claim their rights and for duty-bearers' to fulfil their obligations to support rights holders to claim their rights (including identifying what the rights holders' human rights claims are) [10]. This systematic review will focus on interventions that primarily address a rights-based approach from the rights holder's perspective (rather than those of duty-bearers) in order to include a manageable number of papers and meaningful synthesis.
An effective rights-based approach should enable women to actively take part in decisions regarding their sexual and reproductive health, and challenge those who are preventing them from doing so [11]. The Office of the United Nations High Commissioner for Human Rights (OHCHR) Technical Guidance on rights-based approaches to prevent maternal morbidity and mortality describes a rights-based approach as "premised upon empowering women to claim their rights" [11]. This requires mechanisms for accountability for the vindication of rights, explicit recognition of a woman's right to health (which includes a thorough understanding of sexual and reproductive health in legislation and and/or constitutions), and a focus on health rather than individual pathologies [11].
Previous reviews of rights-based approaches have been limited to certain aspects of sexual and reproductive health. A systematic review, published in 2015, looked at interventions that aimed to promote awareness of rights to increase use of maternity services; results from the four included studies indicated that interventions resulted in an increase in some aspects of service-use, including antenatal care, but studies were of varying quality [12]. The review was limited to maternity services and only included studies that explicitly included awareness-raising (excluding others even if they used rights-based approaches). A more recent systematic review assessed the impact of five aspects of the Joint United Nations Programme on HIV/ AIDS (UNAIDS) categories of human rights programs on HIV-related outcomes between 2003-2015 (human rights and medical ethics training; legal literacy; legal services (HIVrelated); reforming and monitoring regulations, laws and policies related to HIV; law-maker and law enforcement agent sensitisation) [13]. As well as adopting a limited definition of a rights-based approach, the study only focused on HIV-related outcomes. A (non-systematic) literature review of human rights-based approaches to women's and children's health found that rights-based approaches were linked to improved health-related outcomes but was limited to studies using a "participatory approach" [14].
Thus, no systematic review has described the evidence on rights-based approaches to sexual and reproductive health more broadly, including non-HIV and maternity related outcomes such as gender-based violence and other sexually transmitted infections (STI). Policy-makers, governments and health services require evidence on rights-based approaches to sexual and reproductive health to inform the development of interventions and provision of services for their populations. This systematic review examines the evidence on explicitly rights-based approaches to sexual and reproductive health among women living in LMICs.

Methods
The systematic review protocol was registered with PROSPERO on 4/12/2019 (CRD42019158950) [15]. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were followed, as described in the PRISMA flow diagram (Fig 1) and checklist (S1 File).
EMBASE, MEDLINE and Web of Science were searched from inception until 9/1/2020. Search terms included medical subject headings or equivalent and free text terms including sexual health, gender-based violence, maternal health, human rights and more, combined using Boolean operators (S2 File). Search terms were chosen to cover the subject areas of contraception, pregnancy, STIs, awareness of rights, violence and mental health. Reference lists of included studies and relevant identified systematic reviews were screened to identify any further studies not identified in the initial search. There were no language restrictions. Reviews of published studies in languages other than English were conducted by the authors themselves (French, Portuguese) or a University of Warwick colleague, Dr Yen-Fu Chen, (Mandarin). The search strategy was reviewed by a specialist academic librarian. Searches were adapted for each database. Grey literature was not included due to the anticipated lack of detail in the methods of published studies, and anticipated lack of independence of published evaluations (for example, evaluations published by those running an intervention as part of seeking further funding for their organisation or intervention).

Inclusion criteria
• Study design: any interventional study, including randomised controlled trials (RCTs), cohort studies, case-control studies and before-and-after studies.
• Population: females aged over 15 years living in LMICs (defined by the World Bank Group's classification [16]).
• Intervention: any approach the author described as a "rights-based approach", or involving sexual and reproductive health interventions that authors explicitly related to "rights" (for example, an intervention that promoted the awareness of rights). We also included studies based on an intervention referred to as rights-based in another included paper. We only included interventions directed towards women (other than healthcare professionals) or their families. Studies using educational interventions were included in addition to non-educational interventions, as long as they were explicitly described by study authors as related to "rights".
• Comparator: Acceptable comparators included clusters in which no intervention or fewer components of an intervention (for example without the rights-based components) were in place, or individuals not exposed to interventions, or exposed to fewer intervention components.
• Primary outcomes, measured through surveys or routine data (health or crime): • Gender-based violence (prevalence/incidence) • STIs (testing/prevalence/incidence) • Pregnancy and delivery-related outcomes (including antenatal, perinatal and post-partum healthcare access, pregnancy/birth complications) • Perinatal mental health (incidence/prevalence) Following database searches, titles and abstracts were screened by two reviewers independently. Each included full-text article was then reviewed by two reviewers independently. At each state, if there were discrepancies regarding inclusion/exclusion decisions, they were addressed initially via discussion, and if necessary via a third author. Rayyan Systematic Review Web App [17] and Microsoft Excel were used to record decisions.
Data were extracted by two reviewers independently onto a data extraction tool developed by the authors which included basic study details (journal, dates, authors, and location, sample size, population, study design, study duration, interventions, statistical analysis, results, ethics and funding). Only relevant results pertaining to populations eligible for inclusion in this systematic review were extracted-for example, where data was collected for males and females, only data presented on females were extracted.

Analysis
A narrative synthesis of included studies was undertaken. Due to study heterogeneity, metaanalysis was not undertaken. Outcomes were mapped to identify evidence gaps. Effectiveness of identified interventions was examined based on the author's choice of outcomes.
Quality and risk of bias was assessed by two reviewers independently using the RoB-2 tool for cluster-randomised studies [18], and the ROBINS-I tool for non-randomised studies [19]. Uncontrolled before-and-after studies based on two cross-sectional surveys were given an overall assessment of serious or critical risk of bias [20]. Disagreements were addressed via discussion and if necessary via a third author.

Risk of bias in included studies
All studies were classed as high, serious or critical risk of bias, meaning that due to issues with the quality of the studies, there was a substantial risk that included studies overestimated or underestimated the true effect of the interventions. The risk of bias in cluster RCTs and nonrandomised interventional studies is displayed in S1 and S2 Tables respectively. Uncontrolled cross-sectional before-and-after studies were all classified as serious or critical risk of bias (S3 Table).
The remaining eleven studies were undertaken in Bangladesh (married women living in slums) [21], Philippines (FSWs) [22], Tanzania (women in the third trimester of pregnancy) [25], East Nepal (women who had delivered a baby within three years) [26], India (pregnant women [28] and women who had delivered a baby within twelve months [30]), Uganda (women living in rural areas) [29], Kenya (women who had given birth in last 24-48 hours) [42], the Amazon region of Brazil (FSWs-two papers using the same dataset) [34,43], and Egypt (women who were newly married, pregnant or post-partum) [27].
All studies involved multiple components, including various elements alongside (or part of) a rights-based approach. These included education/workshops on rights and sexual health, sexual health service provision, capacity building, advocacy, community mobilisation, peer support and outreach, condom access and promotion, leaflets and posters, and community meetings (Table 1). Table 2 shows the results of each study. Both Benzaken et al. 2003 and2007 [34,43], and Jana et al. 1995 and1998 [41,44] contained data from the same study so are reported together.

Outcomes and results
Condom use. Eleven studies showed a significant positive association between intervention exposure (before-versus-after, self-reported exposure or intervention-versus-control group) and condom use for some [22,31,[33][34][35]37,40,43] or all [24,32,36] of the relevant study population; all of these studies were at serious, high or critical risk of bias. One study, at serious risk of bias, found no significant association [39].
HIV. Ramesh et al. reported a significant reduction in HIV [35], whereas Reza-Paul et al. [36] reported no significant change. Jana et al. [44] reported increased HIV prevalence rates in three consecutive years after intervention implementation, but no statistical significance level was given. All three studies were at critical risk of bias.
Other STIs. Jana et al. reported a non-significant reduction in syphilis [44]. Other studies showed different effects for different STIs [35,36], and Gangopadhyay et al. found no significant effect on lab-proven STI rates [39]. Halli et al. reported increased STI symptoms among those with higher self-reported intervention exposure [37]. All five of these studies had a critical [35,36,44], or serious risk of bias [37,39].
Testing for HIV/STIs. Urada [34,43]. Knowledge of STIs/STI prevention. STI knowledge increased significantly with intervention in three studies [22,24,37], and also increased in Jana et al. who do not provide any data on whether this might have been significant [41]. Halli et al. found this association was not significant in adjusted models [37]. Two of these studies had a serious risk of bias [24,37], and two a critical risk of bias [22,41].  awareness of human rights at follow-up compared to baseline among street-based FSWs but no significant improvement for venue-based FSWs post-intervention, or for awareness of sexual and reproductive health rights (as opposed to human rights) [22]. Ratcliffe et al. (serious risk of bias) reported mixed results in terms of awareness of rights, but no significance tests were undertaken [25]. Metwally et al. (critical risk of bias) reported significant improvements in awareness of rights within a healthcare setting following intervention [27]. Healthcare attendance (STI clinic). Ramesh et al. (critical risk of bias) found higher attendance rates at the project STI clinic post-intervention [35]. Gurnani et al. reported that visits to the project STI clinic increased following intervention but gave no exact figure or statistical test and was at critical risk of bias [23]. Björkman  found increases in antenatal check-ups, giving birth in a healthcare institution and tetanus injections [30].
Rights during delivery. Abuya et al. (critical risk of bias) reported that accessing rights in healthcare (not being humiliated/physically abused, having confidentiality violated, being detained, lack of consent or privacy) significantly increased straight after an educational intervention but those related to verbal aggression or abuse during delivery, examination and abandon did not significantly change [42].
Secondary outcome: Healthcare professionals' awareness of rights. Ratcliffe et al. (serious risk of bias) found non-significant improved awareness among healthcare workers of the importance of confidentiality and awareness that abuse and disrespect are against human rights in maternity care but only percentages were reported (no statistical tests) [25].

Findings
We found that rights-based interventions appear to be effective for certain outcomes within sexual and reproductive health, but evidence is of poor quality. Given the considerable risk of bias across all studies, the results must be interpreted with caution.
Two studies identified increased STI symptoms/diagnosis following intervention, but it is unclear whether this reflects a true increase. For instance, there was an increase in Herpes Simplex Virus-2 diagnosis in Reza-Paul et al.'s study post-intervention but the prevalence of other STIs decreased [36]. Halli et al. found increased STI symptoms among those with higher selfreported intervention exposure, although this could relate to a greater awareness of symptoms among those exposed to the intervention [37].
In keeping with a previous systematic review (mentioned above), which looked at interventions aiming to promote awareness of rights in order to increase use of maternity services [12], our study found mixed results in terms of the effect of interventions on healthcare access during pregnancy and delivery; of the four studies in our systematic review reporting this outcome, three were included in both reviews. The additional study reported no significant effect of intervention on whether women delivered in a healthcare setting (versus at home), whether a skilled birth attendant was present or whether a clean home delivery kit was used [26]. This relative lack of evidence for rights-based approaches in maternity settings is disappointing, and further studies are urgently needed, particularly given the recommendation for rightsbased approaches in the OHCHR Technical Guidance [11].
In contrast to Stangl et al.'s systematic review of the impact of human rights programmes on HIV-related outcomes which found them to be largely effective [13], our systematic review showed mixed results: one study found a reduction in HIV prevalence [35], one reported no change [36] and one reported a significant increase [44] (although all were at critical risk of bias). Interestingly, only one study overlapped between the two systematic reviews, largely due to a different interpretation of a rights-based approach [23]. The overlapping study was limited to outcomes related to news reporting and intervention exposure/service use (not HIVspecific).

Study identification
Many studies identified in this systematic review were not identified from database searching. This is in keeping with a systematic review mentioned above where one of the four studies included was identified from searches and the other three from discussions with experts [12]. This may be because the word 'rights' is not often mentioned in key words, abstracts or titles [12]. We found that even if an intervention was described as related to 'rights' in one paper, another paper evaluating the same intervention (but evaluating different outcomes) did not necessarily refer to the same intervention as related to 'rights'. For example, Reza-Paul et al. described a community mobilisation and outreach intervention as using a "rights-based approach" [36], whilst Ramesh et al.'s study did not mention 'rights' despite evaluating the same intervention [35].
Similarly, another systematic review found that despite the studies included using what authors defined as human rights-based approaches, many studies did not explicitly refer to the protection and promotion of human rights in reference to the intervention being evaluated [13]. Thus, intervention descriptions and whether interventions are 'rights-based' is subjective, and some relevant studies may have been missed in this systematic review. Given the importance of women achieving their sexual and reproductive health rights [6,11], future studies should ensure they are explicit in their use of a rights-based approach or at least refer to 'rights' in relation to the intervention if they are promoted so that the available evidence can be appropriately evaluated.

Outcomes not identified from included studies
Not all important sexual and reproductive health outcomes were identified in the papers included. No results were identified regarding legal action or convictions related to gender-based violence; this is consistent with a previous systematic review of systematic reviews of gender-based violence prevention among adolescent girls in low-income countries which found a paucity of evidence [45]. Gurnani et al. described 4,600 rights violations towards FSWs reported to the police during the study period, and crisis management teams supported 92% of these, but it was unclear whether this was a change from previously [23]. Ratcliffe et al. found that 10% of women who attended their Open Birth Days intervention filed a complaint to the hospital regarding their treatment following the intervention, compared to no women before the intervention, but they did not refer to legal actions or convictions [25]. Additionally, outcomes related to perinatal mental health, unintended pregnancy or abortion, delivery outcomes, female genital mutilation or mental wellbeing were not identified in any included papers.

Limitations
All included studies used complex interventions, usually involving multiple components with rights being some part of it. There was no consistent approach to incorporating rights into programmes. Even in situations where studies found the interventions effective, it was unclear whether or not this was due to the rights-based aspect. Detail regarding interventions in many papers was limited and it was often unclear how the rights-based element was incorporated, exacerbating the challenge in identifying whether a rights-based approach is effective.
Our inclusion criteria were based on the author recognising that the approach was rightsbased and making that explicit. Not having our own definition of what we would consider a rights-based approach means that there may have been studies that were not included, but which examined interventions that did have a rights-based approach. Note that several studies we included did not mention that the interventions studied were rights-based, but because they examined the same intervention that had been described that way in other publications, we included them. This suggests there may be studies our systematic review has missed. Similarly, it is possible that some of the studies included would not have met a strict definition of what a rights-based approach should entail. Reassuringly, none of the included studies were obviously in this category.
Since this systematic review was limited to females, some studies were excluded due to outcomes not being separated by gender, and some outcomes within included studies were also excluded for this reason. For example, Rana et al. included relevant outcomes that were not separated by gender (even if it may be assumed that most people answering the question were women): data were available on knowledge of circumstances when abortion is legal or illegal, HIV and STIs, and contraceptive methods but as these data were not available for women only [26], they were not included in this systematic review.
As discussed, the quality of studies overall was poor. Most studies used an uncontrolled before-and-after study design. These are by nature prone to bias as there is no way of knowing what might have happened without the intervention and what else occurred in the time period which might actually have been responsible for any findings: they are therefore at high risk of confounding [46]. Moreover, some studies did not undertake any statistical analysis of results nor explain why analysis was not undertaken [23,25,41,44]. We did not undertake a meta-analysis due to the heterogeneity of populations, interventions and outcomes. This limited us in undertaking a rigorous estimate of effectiveness.

Conclusions
This is the first systematic review to evaluate the evidence on rights-based approaches to sexual and reproductive health including maternity, gender-based violence, sexual health and HIV.
We undertook a comprehensive search of the literature from three relevant leading electronic databases, as well as reference searching of included studies and relevant systematic reviews. By synthesising the evidence base, we have illuminated the evidence gaps and what should be done in future research to improve the quality of the evidence base. Future research should be more explicit about the use of rights-based approaches and specify more precisely what distinguishes a rights-based approach from others, in a way that would allow evidence to be gathered. Moreover, evidence is needed across a diverse range of populations (not limited to FSWs and maternity settings). Given that rights-based approaches are recommended widely [6,47], high quality (ideally cluster randomised) controlled studies need to be undertaken urgently to determine whether rights-based approaches to sexual and reproductive health are effective in LMICs.
Supporting information S1