Impact of cash transfer programs on healthcare utilization and catastrophic health expenditures in rural Zambia: a cluster randomized controlled trial.

Background: Nearly 100 million people are pushed into poverty every year due to catastrophic health expenditures (CHE). We evaluated the impact of cash support programs on healthcare utilization and CHE among households participating in a cluster-randomized controlled trial focusing on adolescent childbearing in rural Zambia. Methods and findings: The trial recruited adolescent girls from 157 rural schools in 12 districts enrolled in grade 7 in 2016 and consisted of control, economic support, and economic support plus community dialogue arms. Economic support included 3 USD/month for the girls, 35 USD/year for their guardians, and up to 150 USD/year for school fees. Interviews were conducted with 3,870 guardians representing 4,110 girls, 1.5-2 years after the intervention period started. Utilization was defined as visits to formal health facilities, and CHE was health payments exceeding 10% of total household expenditures. The degree of inequality was measured using the Concentration Index. In the control arm, 26.1% of the households utilized inpatient care in the previous year compared to 26.7% in the economic arm (RR = 1.0; 95% CI: 0.9-1.2, p = 0.815) and 27.7% in the combined arm (RR = 1.1; 95% CI: 0.9-1.3, p = 0.586). Utilization of outpatient care in the previous 4 weeks was 40.7% in the control arm, 41.3% in the economic support (RR = 1.0; 95% CI: 0.8-1.3, p = 0.805), and 42.9% in the combined arm (RR = 1.1; 95% CI: 0.8-1.3, p = 0.378). About 10.4% of the households in the control arm experienced CHE compared to 11.6% in the economic (RR = 1.1; 95% CI: 0.8-1.5, p = 0.468) and 12.1% in the combined arm (RR = 1.1; 95% CI: 0.8-1.5, p = 0.468). Utilization of outpatient care and the risk of CHE was relatively higher among the least poor than the poorest households, however, the degree of inequality was relatively smaller in the intervention arms than in the control arm. Conclusions: Economic support alone and in combination with community dialogue aiming to reduce early childbearing did not appear to have a substantial impact on healthcare utilization and CHE in rural Zambia. However, although cash transfer did not significantly improve healthcare utilization, it reduced the degree of inequality in outpatient healthcare utilization and CHE across wealth groups. Trial Registration: https://classic.clinicaltrials.gov/ct2/show/NCT02709967, ClinicalTrials.gov, identifier (NCT02709967).

Impact of an integrated health, nutrition, and early child stimulation and responsive care intervention package delivered to preterm or term small for gestational age babies during infancy on growth and neurodevelopment: study protocol of an individually randomized controlled trial in India (Small Babies Trial).

BACKGROUND: Preterm and term small for gestational age (SGA) babies are at high risk of experiencing malnutrition and impaired neurodevelopment. Standalone interventions have modest and sometimes inconsistent effects on growth and neurodevelopment in these babies. For greater impact, intervention may be needed in multiple domains-health, nutrition, and psychosocial care and support. Therefore, the combined effects of an integrated intervention package for preterm and term SGA on growth and neurodevelopment are worth investigating. METHODS: An individually randomized controlled trial is being conducted in urban and peri-urban low to middle-socioeconomic neighborhoods in South Delhi, India. Infants are randomized (1:1) into two strata of 1300 preterm and 1300 term SGA infants each to receive the intervention package or routine care. Infants will be followed until 12 months of age. Outcome data will be collected by an independent outcome ascertainment team at infant ages 1, 3, 6, 9, and 12 months and at 2, 6, and 12 months after delivery for mothers. DISCUSSION: The findings of this study will indicate whether providing an intervention that addresses factors known to limit growth and neurodevelopment can offer substantial benefits to preterm or term SGA infants. The results from this study will increase our understanding of growth and development and guide the design of public health programs in low- and middle-income settings for vulnerable infants. TRIAL REGISTRATION: The trial has been registered prospectively in Clinical Trial Registry - India # CTRI/2021/11/037881, Registered on 08 November 2021.

The impact of COVID-19-related restrictions on pregnancy and abortion rates in the Republic of Georgia.

BACKGROUND: The Republic of Georgia implemented COVID-19-related restrictions starting on 31 March 2020, when it imposed a 1-month strict lockdown, after which the country continued with some form of restrictions for 1 year. These restrictions created barriers to healthcare access, affected healthcare services, caused severe economic degradation, and changed reproductive behavior. The aim of this study was to explore the impact of COVID-19-related restrictions on pregnancy and abortion rates in Georgia. METHODS: Information on pregnancy, abortion, and related variables was extracted from the Georgian Birth Registry from January 2018 through April 2022. The final study sample included 232,594 pregnancies and 86,729 abortions. We used interrupted time series analysis to study the impact of COVID-19-related restrictions. RESULTS: There were slightly decreasing trends in pregnancy and abortion rates in the pre-pandemic period (1 January 2018-31 March 2020). During the 1-month strict lockdown (1 April-30 April 2020), pregnancy and abortion rates decreased in all investigated age groups. There were no substantial differences in pregnancy or abortion rates in the pandemic period (for pregnancies: 1 April 2020-30 June 2021; for abortions: 1 April 2020-30 April 2022) compared to the pre-pandemic period. The precision of all estimates suggested that both small increases and decreases in pregnancy and abortion rates are reasonably compatible with our data. CONCLUSIONS: Despite the 1-year-long COVID-19-related restrictions, our results did not indicate substantial long-term changes in pregnancy or abortion rates during the study period for any age group. This may indicate that the restrictions did not substantially influence access to contraception, abortion services, or reproductive behavior.

Time trends in perinatal outcomes among HIV-positive pregnant women in Northern Tanzania: A registry-based study.

INTRODUCTION: Maternal HIV infection is associated with increased risk of having a preterm delivery, low birth weight baby, small for gestational age baby and stillbirth. Maternal use of combination antiretroviral treatment is also associated with preterm delivery and low birth weight, although the effects vary by the type of drugs and timing of initiation. OBJECTIVE: To examine time trends in adverse perinatal outcomes among HIV-positive compared with HIV-negative women. DESIGN: Registry-based cohort study. SETTING: Northern Tanzania, 2000-2018. STUDY SAMPLE: Mother-baby pairs of singleton deliveries (n = 41 156). METHODS: Perinatal outcomes of HIV-positive women were compared with HIV-negative women during time periods representing shifts in prevention of mother-to-child transmission guidelines. Monotherapy was used as first-line therapy before 2007 while combination antiretroviral treatment was routinely used from 2007. Log binomial and quantile regression were used to analyze the data. MAIN OUTCOME MEASURES: Preterm delivery, low birth weight, perinatal death, stillbirth, low Apgar score, transfer to neonatal care unit and small for gestational age. RESULTS: Overall, maternal HIV infection was associated with a higher risk of low birth weight and small for gestational age. Moreover, this pattern became more pronounced over time for low birth weight, the last time period being an exception. For other outcomes we found none or only a small overall association with maternal HIV infection, although a trend towards higher risk over time in HIV-positive compared with HIV-negative women was observed for preterm delivery and perinatal death. Quantile regression showed an increase in birth weight in babies born to HIV-negative women over time and a corresponding decline in birth weight in babies born to HIV-positive women. CONCLUSION: Unfavourable trends in some of the selected perinatal outcomes were seen for HIV-positive compared with HIV-negative women. Potential side-effects of combination antiretroviral treatment in pregnancy should be further explored.

Maternal antiretroviral treatment for HIV infection and risk of small-for-gestational-age birth: A systematic review and meta-analysis of protease inhibitor-based treatment and timing of treatment.

BACKGROUND: Data indicate that certain combination antiretroviral treatment (cART) regimens, particularly protease inhibitor (PI)-based regimens, and cART initiation before conception may be associated with adverse pregnancy outcomes. The risk of having a small-for-gestational-age (SGA) infant was examined among pregnant HIV-infected mothers on 1) PI-based compared to non-PI-based cART, and 2) any cART initiated before compared to after conception. METHODS: A search was conducted using PubMed, Embase, and the Cochrane Library, and a systematic review was performed of studies published since Dec 1, 1995. Effect estimates with 95% confidence intervals (CIs) were extracted and meta-analyses with random-effects models were conducted. The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation tool. FINDINGS: Of 783 identified studies, 28 fulfilled the inclusion criteria. Meta-analysis indicated that PI-based cART was associated with a possible slightly increased risk of SGA compared with non-PI-based cART (pooled odds ratio [OR]: 1·09; CI: 0·76, 1·55). Initiation of cART before conception was also associated with a possible slightly increased risk of SGA compared with after conception (pooled OR: 1·08; CI: 0·95, 1·22). The overall certainty of evidence was very low and low for the first and second research questions, respectively. INTERPRETATION: Although the benefits of cART largely outweigh the risks, these findings indicate the possibility of slightly increased risks of having an SGA infant. This indicates that careful monitoring of fetuses exposed to PI-based cART or cART before pregnancy might be reasonable. Based on the uncertainty of evidence, further research may change this conclusion.

Examining the association between HIV prevalence and socioeconomic factors among young people in Zambia: Do neighbourhood contextual effects play a role?

BACKGROUND: The study examined the association between HIV infection and individual and neighbourhood-level socioeconomic factors in Zambia. METHODS: We used multilevel mixed effects logistic regression to examine the association of individual and neighbourhood level variables on HIV prevalence based on data from the 2013-14 and 2018 Zambia Demographic and Health Surveys, population-based cross-sectional surveys. The analysis was restricted to young people (15-24 years) with HIV serostatus results (n = 11,751 and n = 10,154). HIV serostatus was the outcome variable and socioeconomic status was measured by wealth, education and employment. RESULTS: Overall, at individual level, education was associated with reduced odds of HIV infection among young women and men. Conversely, relative wealth was generally associated with increased odds of infection for both young women and men. Young, employed men were at reduced odds of HIV infection than the unemployed. Living in neighbourhoods with higher average level of education was associated with higher odds of HIV infection. In 2013-14, 13% and 11% of the variation in HIV infection among young men and women was attributed to neighbourhoods, while 20% and 11% variation was attributed to neighbourhoods in 2018. Inclusion of individual and neighbourhood variables in the full regression model accounted for 65.7% and 59.5% of explained variance in 2013-14 and 64.6% and 44.3% in 2018, for women and men, respectively. This reduced unexplained variance by an average of 56% in 2013-14 and 29% in 2018. CONCLUSION: We found that HIV infection among young people in Zambia is more strongly associated with individual-level socioeconomic factors compared to neighbourhood factors. Individual-level education remains an important socioeconomic factor associated with reduced odds of HIV infection. This suggests that the HIV response in Zambia should still focus on individual level prevention strategies.

Effects of economic support, comprehensive sexuality education and community dialogue on sexual behaviour: Findings from a cluster-RCT among adolescent girls in rural Zambia.

Adolescent girls in Sub-Saharan Africa are at high risk of poor sexual and reproductive health outcomes. We present findings from a cluster-randomised trial in rural Zambia on the effects of economic support, comprehensive sexuality education (CSE) and community dialogue on sexual activity, contraceptive use and beliefs among adolescent girls. We recruited 157 schools in 2016, and all girls in grade 7 were invited to participate. Schools were randomised to either economic support, combined economic support, CSE and community dialogue, or control. Economic support consisted of unconditional cash transfers to girls and their guardians, and payment of school fees for girls continuing to grades eight and nine. CSE and community dialogue meetings focused on practices around girls' fertility, marriage and education. The interventions lasted two years from 2016 to 2018, with follow-up for another two years. The effects on outcomes were measured in 2018 and 2019 and compared using generalised estimating equations. We found that economic support lowered sexual activity (risk ratio (RR) 0.70; 95% C.I. 0.54 to 0.91), with a small added benefit of CSE and community dialogue. Economic support and the additional CSE and community dialogue were effective in lowering unprotected sexual activity (RR 0.53 for combined support vs. control; 95% C.I. 0.37 to 0.75). There was no evidence of intervention effects on contraceptive use among those ever sexually active, but the addition of CSE and community dialogue improved contraceptive use among those recently sexually active (RR 1.26; 95% C.I. 1.06 to 1.50) and knowledge regarding contraceptives (RR 1.18; 95% C.I. 1.01 to 1.38) compared to economic support alone. Perceived community support regarding contraceptives was lower in both intervention arms compared to the control. These findings indicate that economic support in combination with CSE and community dialogue can improve the sexual and reproductive health of adolescent girls.

Combining photo-elicitation and discourse analysis to examine adolescents' sexuality in rural Zambia.

INTRODUCTION: This article aimed to analyse constructions of adolescents' sexualities and sexual health and the consequences of these discourses for adolescents' exercise of their sexual reproductive health and rights (SRHR) in rural Zambia. METHODS: Interpretative repertoires, which is rooted in discursive psychology was used to analyse data from photo-elicitations interviews and focus group discussions. Our participants included 25 adolescents who participated in a SRHR intervention that aimed to reduce adolescents' pregnancies and early marriages. RESULTS: We identified three interpretative repertories: 1) sex is for mature people in which adolescents positioned themselves as 'immature, and young to engage in sex; 2) gendered respectful behaviours in which what was considered disrespectful (and respectful) behaviour in relation to sexuality were strongly influenced by gender, and more clearly defined for girls than it was for boys. Sexuality was not only about individual choices but about being respectful to parents; and 3) acquiring and using knowledge about sexuality in which adolescents conflicted between having and applying SRHR knowledge. CONCLUSION: These repertories offer an important context that shape how adolescents negotiate, adopt and resist SRHR interventions. Future interventions that target adolescents' SRHR must aim to address the sexual scripts that serve to erect barriers against positive sexual behaviours, including access to SRHR services that promote safer sex.

Application of community dialogue approach to prevent adolescent pregnancy, early marriage and school dropout in Zambia: a case study.

BACKGROUND: Adolescent pregnancy carries both health and economic risks for the pregnant girl and resulting baby, and it is common in Zambia. Providing alternative methods of preventing early pregnancy than abstinence is regarded as culturally and religiously unacceptable in most parts of the country. The community dialogue approach is being tested to address norms and beliefs around early pregnancy, marriage and school dropout, and is based on Paulo Freire's transformative communication approach. The objective of this paper was to understand parents' perspectives on the application of the community dialogue approach in addressing adolescents' early pregnancy and school dropout in a cluster randomized controlled trial in rural Zambia. METHODS/DESIGN: This was a case study design. We nested the study in the community dialogue intervention arm of the Research Initiative to Support the Empowerment of Girls trial in Zambia. Dialogue meetings were held and economic support was provided for a period of 27 months from September 2016 until November 2018. We held focus group discussions in November 2018 with guardians/parents in six schools in Chibombo District of Central Province. All the discussions were audio recorded and transcribed verbatim. Thematic analysis was used to analyze the data. RESULTS: The guardians/parents perceived the community dialogue to be a relevant approach for addressing social and cultural norms regarding early pregnancy, marriage and school dropout. It was embraced for its value in initiating individual and collective change. The facilitators' interactive approach and dialogue in the community meetings coupled with the use of films and role plays with the parents, lead to active participation and open discussions about sexual and reproductive health (SRH) topics during the community dialogue meetings. Group interactions and sharing of experiences helped parents clarify their SRH values and subsequently made them feel able to communicate about SRH issues with their children. However, cultural and religious beliefs among the parents regarding some topics, like the use of condoms and contraceptives, complicated the delivery of reproductive health messages from the parents to their children. CONCLUSION: The study indicated that the community dialogue was appreciated by the parents and helped in addressing cultural barriers to discussing SRH issues between generations.

Interviewing adolescent girls about sexual and reproductive health: a qualitative study exploring how best to ask questions in structured follow-up interviews in a randomized controlled trial in Zambia.

BACKGROUND: Numerous studies have documented inconsistent reporting of sexual behaviour by adolescents. The validity and reliability of self-reported data on issues considered sensitive, incriminating or embarrassing, is prone to social-desirability bias. Some studies have found that Audio Computer-Assisted Self Interviewing (ACASI) that removes the personal interaction involved in face-to-face interviews, decreases item non-response and increases reporting of sensitive behaviours, but others have found inconsistent or contradictory results. To reduce social desirability bias in the reporting of sensitive behaviours, face-to-face interviews were combined with ACASI in a cluster randomized trial involving adolescents in Zambia. METHODS: To explore adolescent girls' experiences and opinions of being interviewed about sexual and reproductive health, we combined Focus Group Discussions with girl participants and individual semi-structured interviews with teachers. This study was done after the participants had been interviewed for the 6th time since recruitment. Young, female research assistants who had conducted interviews for the trial were also interviewed for this study. RESULTS: Respondents explained often feeling shy, embarrassed or uncomfortable when asked questions about sex, pregnancy and abortion face-to-face. Questions on sexual activity elicited feelings of shame, and teachers, research assistants and girls alike noted that direct questions about sexual activities limit what the participant girls may be willing to share. Responding to more indirect questions in relation to the context of a romantic relationship was slightly easier. Efforts by interviewers to signal that they did not judge the participants for their behavior and increased familiarity with the interviewer reduced discomfort over time. Although some appreciated the opportunity to respond to questions on their own, the privacy offered by ACASI also provided an opportunity to give false answers. Answering on tablets could be challenging, but participants were reluctant to ask for assistance for fear of being judged as not conversant with technology. CONCLUSION: Strategies to avoid using overly direct language and descriptive words, asking questions within the context of a romantic relationship and a focus on establishing familiarity and trust can reduce reporting bias. For the use of ACASI, considerations must be given to the context and characteristics of the study population.

Numerous studies have found that adolescents may not answer truthfully or consistently when questioned about issues such as sexual activity, abortion and pregnancy. Such issues are considered sensitive, incriminating, or embarrassing, and answers may be influenced by a fear of being misjudged or sanctioned. In an attempt to collect more reliable data on sexual behaviour and childbearing, we combined face-to-face interviews with Audio Computer-Assisted Self Interviewing (ACASI) in a research trial involving adolescents in Zambia. In this study we aimed to explore adolescent girls' experiences and opinions of being interviewed about sexual and reproductive health when participating in the trial. We combined group discussions with girl participants and individual interviews with teachers. Participants said they felt shy, embarrassed or uncomfortable when asked questions about sex, pregnancy and abortion face-to-face. Teachers, girls and interviewers alike noted that very direct questions limit what the participants may be willing to share. Efforts by interviewers to signal that they did not judge the participants for their behaviour, and repeated interviews with the same interviewer reduced discomfort over time. Some liked ACASI whereas some said it made it easier to give false answers, and answering on electronic tablets could be challenging. To reduce embarrassment and increase the likelihood of honest answers we recommend avoiding overly direct language and descriptive words, and to relate questions about sexual activity to a romantic relationship. Interviewers who are able to establish familiarity and trust can make participants more comfortable.

Norms and sexual relations among adolescents in the context of an intervention trial in rural Zambia.

High levels of adolescent pregnancy and child marriage rates in low- and middle-income countries is an issue of concern to many stakeholders, including in Zambia where almost one-third of women give birth before age 18. The aim of this paper is to explore and analyse social norms concerning adolescents' sexual behaviour within the context of an intervention trial in rural communities in southern Zambia. It is based on a qualitative study applying individual interviews, focus group discussions and participatory research methods. We apply the distinction between injunctive and descriptive norms to demonstrate that adolescent girls are caught between conflicting norms. Injunctive norms express that premarital sex, contraceptive use, and discussions about sex between adults and youths are socially condemned. At the same time poor girls are reported to feel pressure towards having sexual relations for the economic benefits such relations can bring, and this practice is considered so common that it amounts to a descriptive norm. Norms and structural conditions combine to create a disabling and disempowering environment for adolescent sexual and reproductive health, which limits girls' agency and exposes them to unwanted pregnancies.

Experiences of teachers and community health workers implementing sexuality and life skills education in youth clubs in Zambia.

Zambia, like other low- and middle-income countries, faces numerous adolescent sexual and reproductive health challenges such as teenage pregnancies. This study aimed at understanding teachers' and community health workers' (CHWs) implementation of comprehensive sexuality education (CSE) as part of a comprehensive support package for adolescent girls to prevent early childbearing. Data collected using in-depth interviews [n = 28] with teachers [n = 15] and community health workers [n = 13] were analysed using thematic analysis. The teachers and CHWs reported that the use of participatory approaches and collaboration between them in implementing CSE enabled them to increase girls' and boys' participation youth clubs. However, some teachers and CHWs experienced practical challenges with the manuals because some concepts were difficult to understand and translate into local language. The participants perceived that the youth club increased knowledge on CSE, assertiveness and self-esteem among the learners. Training and providing a detailed teaching manual with participatory approaches for delivering CSE, and collaborative teaching enabled teachers and CHWs to easily communicate sensitive SRH topics to the learners. However, for the adoption of CSE to be even more successful, piloting of the curriculum with local facilitators and translating the manuals into the local languages before they are implemented, is recommended.

Vanilla bisquits and lobola bridewealth: parallel discourses on early pregnancy and schooling in rural Zambia.

BACKGROUND: Adolescent pregnancy is a complex socio-economic phenomenon ranking high on the global health policy agenda. Early childbearing is associated with early marriage and school drop-out, and is defined as a problem to the health and development of girls. This paper reports from formative research. The formative research aimed to explore socio-cultural and structural dynamics at work behind early pregnancy and school drop out in rural Zambia. The study findings have been used to inform a school based intervention to reduce early pregnancy (RISE: 'Research Initiative to Support the Empowerment of Girls'). Theoretically the study is informed by social constructionism. METHODS: A qualitative approach was employed. Semi-structured qualitative interviews (61) and focus group discussions (7) were carried out with girls (in and out of school), boys, parents, teachers, health workers and community- and district leaders in 2014-15. Systematic text condensation was drawn upon in the analysis of the material. RESULTS: The study findings indicate that the official Zambian discourse that presents early pregnancy as a serious challenge and schooling as the prime way to confront the problem enjoy substantial support at community levels. However, a parallel discourse on fertility, early marriage and childbearing as social and economic security surfaced and was articulated by the same study participants. The latter contrasting discourse questioned schooling as the only solution to secure a girl's future arguing that there are many reasons why early pregnancy may emerge as rational. CONCLUSIONS: Grasping the complexity of local discourse is vital in planning health interventions. The present study revealed that although delayed child bearing and schooling among girls enjoyed high status and legitimacy in the study area, the social and economic context worked to reward early marriage. Interventions to reduce early pregnancies in rural Zambian communities need to fundamentally address the material constraints that condition and reinforce a culture of early childbearing.

Patient and health system costs of managing pregnancy and birth-related complications in sub-Saharan Africa: a systematic review.

BACKGROUND: Morbidity and mortality due to pregnancy and childbearing are high in developing countries. This study aims to estimate patient and health system costs of managing pregnancy and birth-related complications in sub-Saharan Africa. METHODS: A systematic review of the literature was conducted to identify costing studies published and unpublished, from January 2000 to May 2019. The search was done in Pubmed, EMBASE, Cinahl, and Web of Science databases and grey literature. The study was registered in PROSPERO with registration No. CRD42019119316. All costs were converted to 2018 US dollars using relevant Consumer Price Indices. RESULTS: Out of 1652 studies identified, 48 fulfilled the inclusion criteria. The included studies were of moderate to high quality. Spontaneous vaginal delivery cost patients and health systems between USD 6-52 and USD 8-73, but cesarean section costs between USD 56-377 and USD 80-562, respectively. Patient and health system costs of abortion range between USD 11-66 and USD 40-298, while post-abortion care costs between USD 21-158 and USD 46-151, respectively. The patient and health system costs for managing a case of eclampsia range between USD 52-231 and USD 123-186, while for maternal hemorrhage they range between USD 65-196 and USD 30-127, respectively. Patient cost for caring low-birth weight babies ranges between USD 38-489 while the health system cost was estimated to be USD 514. CONCLUSION: This is the first systematic review to compile comprehensive up-to-date patient and health system costs of managing pregnancy and birth-related complications in sub-Saharan Africa. It indicates that these costs are relatively high in this region and that patient costs were largely catastrophic relative to a 10 % of average national per capita income.

Parent-child communication about sexual issues in Zambia: a cross sectional study of adolescent girls and their parents.

BACKGROUND: Parent-child communication about sexual issues can reduce risky sexual behaviour amongst adolescents. Risky sexual behaviour is of concern in sub-Saharan Africa where the prevalence of early pregnancy, unsafe abortion and HIV are high. Parent-child communication about sexual issues presents a feasible approach for reducing sexual risk amongst adolescents in sub-Saharan Africa but limited research exists from the region. This study from Zambia examines the sociodemographic and psychosocial factors that are associated with whether parents communicate with their daughters about sexual issues. METHODS: Data from a cluster randomized controlled trial examining the effect of interventions aiming to reduce teenage pregnancy and school drop out in Zambia was used. The data was collected between January-July in 2018 and consists of structured, face to face interviews with 4343 adolescent girls and 3878 parents. Cross sectional analyses examined the associations between parent-child communication about sexual issues and sociodemographic and psychosocial characteristics using univariate and multivariable logistic regression models. RESULTS: Adolescent girls who felt connected to their parents and those who perceived their parents to be comfortable in communicating about sex, were more likely to speak to their parents about sexual issues than those who did not (AOR 1.23, 95% CI 1.01-1.52; and AOR 2.94, 95% CI 2.45-3.54, respectively). Girls whose parents used fear-based communication about sexual issues, and those who perceived their parents as being opposed to education about contraception, were less likely to communicate with their parents about sex than those who did not (AOR 0.76, 95% CI 0.65-0.89; and AOR 0.76, 95% CI 0.63-0.91, respectively). Girls enrolled in school were less likely to communicate with their parents about sex than those out of school (AOR 0.56, 95% CI 0.44-0.71). CONCLUSION: Parenting style, children's perception of parental attitudes and parental communication styles are associated with whether parents and children communicate about sexual issues. This may imply that parents can improve the chances of communicating with their children about sex by conveying non-judgemental attitudes, using open communication styles with neutral messages and appearing comfortable whilst displaying positive attitudes towards communication around sex and contraceptive use. TRIAL REGISTRATION: ISRCTN registry: ISRCTN12727868 , (4 March 2016).

Acceptability of youth clubs focusing on comprehensive sexual and reproductive health education in rural Zambian schools: a case of Central Province.

BACKGROUND: The youths in Zambia have limited access to information concerning Sexual Reproductive Health (SRH) and this puts them at risk of unwanted pregnancies. Talking about other methods of preventing pregnancy or sexually transmitted infections than abstinence is regarded as culturally unacceptable. The Research Initiative to Support the Empowerment of Girls (RISE) is a cluster randomised controlled trial testing the effectiveness of different support packages on teenage pregnancies, early marriages and school drop-out rates. One of the support packages included youth clubs focusing on Comprehensive Sexual and Reproductive Health Education (CSRHE). Although similar interventions have been implemented in other settings, their integration process has been complex and comprehensive assessments of factors shaping acceptability of CSRHE are lacking. This article qualitatively aimed at identifying factors that shaped the acceptability of CSRHE youth clubs in rural schools in Central Province. METHOD: A qualitative case study was conducted after the youth clubs had been running for a year. Data were gathered through eight focus group discussions with grade eight pupils and eight individual interviews with teachers. Data were analysed using thematic analysis. RESULTS: The perceived advantage and simplicity of the clubs related to the use of participatory learning methods, films and role plays to communicate sensitive reproductive health information made the learners like the youth clubs. Further, the perceived compatibility of the content of the sessions with the science curriculum increased the learners' interest in the youth clubs as the meetings also helped them to prepare for the school examinations. However, cultural and religious beliefs among teachers and parents regarding the use of contraceptives complicated the delivery of reproductive health messages and the acceptability of youth clubs' information among the learners. CONCLUSION: The study indicated that CSRHE youth clubs may be acceptable in rural schools if participatory learning methods are used and head-teachers, teachers as well as parents appreciate and support the clubs.

Can sexual health interventions make community-based health systems more responsive to adolescents? A realist informed study in rural Zambia.

INTRODUCTION: Community-based sexual reproductive interventions are key in attaining universal health coverage for all by 2030, yet adolescents in many countries still lack health services that are responsive to their sexual reproductive health and rights' needs. As the first step of realist evaluation, this study provides a programme theory that explains how, why and under what circumstances community-based sexual reproductive health interventions can transform (or not) 'ordinary' community-based health systems (CBHSs) into systems that are responsive to the sexual reproductive health of adolescents. METHODS: This realist approach adopted a case study design. We nested the study in the full intervention arm of the Research Initiative to Support the Empowerment of Girls trial in Zambia. Sixteen in-depth interviews were conducted with stakeholders involved in the development and/or implementation of the trial. All the interviews were recorded and analysed using NVIVO version 12.0. Thematic analysis was used guided by realist evaluation concepts. The findings were later synthesized using the Intervention-Context-Actors-Mechanism-Outcomes conceptualization tool. Using the retroduction approach, we summarized the findings into two programme theories. RESULTS: We identified two initial testable programme theories. The first theory presumes that adolescent sexual reproductive health and rights (SRHR) interventions that are supported by contextual factors, such as existing policies and guidelines related to SRHR, socio-cultural norms and CBHS structures are more likely to trigger mechanisms among the different actors that can encourage uptake of the interventions, and thus contribute to making the CBHS responsive to the SRHR needs of adolescents. The second and alternative theory suggests that SRHR interventions, if not supported by contextual factors, are less likely to transform the CBHSs in which they are implemented. At individual level the mechanisms, awareness and knowledge were expected to lead to value clarification', which was also expected would lead to individuals developing a 'supportive attitude towards adolescent SRHR. It was anticipated that these individual mechanisms would in turn trigger the collective mechanisms, communication, cohesion, social connection and linkages. CONCLUSION: The two alternative programme theories describe how, why and under what circumstances SRHR interventions that target adolescents can transform 'ordinary' community-based health systems into systems that are responsive to adolescents.

Community perspectives on randomisation and fairness in a cluster randomised controlled trial in Zambia.

BACKGROUND: One important ethical issue in randomised controlled trials (RCTs) is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of randomisation such as equality, fairness, transparency and accountability in community-based trials. The aim of this study was to understand and explore study communities' perspectives of the randomisation process in a cluster RCT in rural Zambia studying the effectiveness of different support packages for adolescent girls on early childbearing. METHODS: In this explorative study, in-depth semi-structured interviews were carried out in 2018 with 14 individuals who took part in the randomisation process of the Research Initiative to Support the Empowerment of Girls (RISE) project in 2016 and two traditional leaders. Two of the districts where the trial is implemented were purposively selected. Interviews were audio recorded and fully transcribed. Data were analysed by coding and describing emergent themes. RESULTS: The understanding of the randomisation process varied. Some respondents understood that randomisation was conducted for research purposes, but most of them did not. They had trouble distinguishing research and aid. Generally, respondents perceived the randomisation process as transparent and fair. However, people thought that there should not have been a "lottery" because they wanted all schools to receive equal or balanced benefits of the interventions. CONCLUSIONS: Randomisation was misunderstood by most respondents. Perceived procedural fairness was easier to realize than substantive fairness. Researchers working on Cluster Randomised Controlled Trials (CRCTs) should consider carefully how to explain randomisation.

Acceptability of an economic support component to reduce early pregnancy and school dropout in Zambia: a qualitative case study.

Background: Cash Transfer (CT) schemes have become popular poverty reducing measures in many low and middle-income countries. Research indicates that when provided to girls in resource poor settings, cash transfers can increase education and postpone marriage and pregnancy. However, a few studies indicate that they can also have negative effects which can affect their acceptability, such as generating intra-community tensions.Objective: Conceptually informed by Rogers' diffusion of innovation theory, this paper explores factors affecting the acceptability of economic support in a randomized controlled trial in rural Monze and Pemba Districts of Southern Province in Zambia.Methods: Qualitative data were collected through five focus group discussions and six in-depth, semi-structured interviews and analysed using thematic analysis. This study was done in the combined arm of a trial where girls received both economic support and participated in youth clubs offering sexuality and life-skills education.Results: In the study communities, acceptability was encouraging by the belief that economic support provided benefits beyond beneficiaries and that it improved access to education, and reduced teen pregnancies, marriages and school drop-out. However, provision of economic support only to selected girls and their parents and fear among some that the support was linked to satanic practices negatively affected acceptability. These fears were mitigated through community sensitisations.Conclusion: The study demonstrated that relative advantage, observability, simplicity and compatibility were key factors in influencing acceptability of the economic support. However, to enhance acceptability of cash transfer schemes aimed at addressing early marriage and pregnancy, it is important to explore socio-cultural factors that create suspicions and negative perceptions and to provide schemes that are perceived as relatively better than available similar schemes, understood, compatible and viable beyond the immediate beneficiary.

The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study.

BACKGROUND: There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot study of a school-based pregnancy prevention intervention in rural Zambia, the majority of the guardians who were asked to consent to their daughters' participation, refused. In this paper we explore the reasons behind the low participation in the pilot with particular attention to challenges related to the community engagement and informed consent process. METHODS: The pilot was implemented in two schools and examined the acceptability of a package of interventions including economic support to families to keep their girls in school, pocket money for girls, youth club meetings on reproductive health, and community meetings to sensitize the community. Focus group discussions (4) were conducted with girls who participated in the pilot, boys in their class and with parents. Individual semi-structured interviews (11) were conducted with teachers, peer educators and community health workers involved in the coordination of the intervention as well as with religious and traditional leaders. Data were analyzed through thematic analysis. RESULTS: The findings indicate that inadequate use of recognized community communication channels during the community engagement process and dissemination of information about the pilot resulted in limited understanding of the pilot concept by the community. This surfaced through uncertainty and fear that the intervention may result in loss of control over daughters, worries about why money was provided unconditionally to girls, and suspicion of links to satanism. The sense of insecurity appeared to be exacerbated by low literacy levels, poverty, fear of loss of bride wealth, perceived disregard for local perceptions of social status, and scanty trust in the actors implementing the pilot. CONCLUSIONS: Inadequate use of locally appropriate channels in the dissemination of information created room for interpretation and facilitated development of mistrust, undermining the conditions for community engagement and actual informed consent. A key lesson learnt is the importance of taking seriously the complexity of local values and structures that may impact people's capability to consent or not consent to a study in an informed manner.