Turned away and sleeping apart: A qualitative study on women's perspectives and experiences with family planning denial in Malawi.

INTRODUCTION: Barriers to family planning for potential clients have been explored in the literature, but rarely from the perspective of the women themselves in a low-income setting. This research aimed to understand clients' perspectives on being turned away from receiving a method of family planning at a facility on the day it was sought. METHODS: Three focus group discussions were held in two districts of Malawi in 2019 with clients who had been turned away approximately three to six months prior. RESULTS: The reasons for turnaway participants mentioned fell into eight categories: no proof of not being pregnant, method and/or supply stock-outs, arriving late, provider unavailable, provider refusal, needing to wait longer after delivery of a child, financial constraints, and medical reasons. Participants were often turned away more than once before finally being able to initiate a method, in some cases returning to the same facility and in others finding it through community health workers, traditional healers, or private facilities. Clients often resorted to sleeping apart from their husbands until they could initiate a method and reported stress and worry resulting from being turned away. CONCLUSIONS: Clients are turned away without a method of FP on the day they seek one for multiple reasons, nearly all of which are preventable. Many examples given by the participants showed a lack of knowledge and respect for clients on the part of the providers. Changing attitudes and behaviour, however, may be difficult and will require additional steps. Increasing the availability and use of pregnancy tests, having a more reliable supply of methods and materials, increasing the number of providers-including those trained well in all methods-and providing daily FP services would all help reduce turnaway. Improved access to family planning will help counties achieve their Sustainable Development Goals.

Testing a counseling message for increasing uptake of self-injectable contraception in southern Malawi: A mixed-methods, clustered randomized controlled study.

OBJECTIVE: While self-injection of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) has well-documented benefits, uptake may be improved by addressing client concerns such as fear of self-injury and low self-efficacy. However, current training materials for family planning providers do not address these concerns. We used an iterative process with family planning providers and clients, male community leaders and partners, and stakeholders in Malawi to develop a counseling message addressing user-centered concerns about self-injection. We report on our testing of the effectiveness of this evidence-based message for increasing self-injection uptake in the context of full method choice. METHODS: We randomized 60 public facilities across two districts in southern Malawi to orient their providers to the message (treatment) or not (control). After strengthening data quality, we extracted routine service delivery data from the facilities six months before and after introducing the message. We compared pre- and post-orientation trends for the treatment and control groups using generalized linear mixed models. We conducted eight focus group discussions with a sample of providers oriented to the message. RESULTS: The message was feasible to implement and highly acceptable to providers. During June 2020-June 2021, 16,593 new clients used injectables in Mangochi district (52% DMPA-SC; 15% self-injected). In Thyolo district, 7,761 new clients used injectables during July 2020-July 2021 (29% DMPA-SC; 14% self-injected). We observed high variability in number of clients and self-injection uptake across facilities and over time, indicating inconsistent offering of self-injection. In both districts, we found significant increases in self-injection in treatment facilities after message introduction. However, this increase was not sustained, especially when DMPA-SC was unavailable or about to expire. CONCLUSION: Based on the study findings, we recommend the evidence-based message be used in programs offering DMPA-SC self-injection services. However, effective use of the message is contingent upon a consistent supply of DMPA-SC.

Facilitators and barriers to participation in health mothers' groups in improving maternal and child health and nutrition in Nepal : A mixed-methods study.

BACKGROUND: In Nepal, Health Mother's Groups (HMG) are women's group-based programmes for improving maternal and child health. However, they remain underutilised with only 27% of reproductive-aged women participating in an HMG meeting in 2016. This study aimed to understand the facilitators and barriers to HMG meeting participation. METHODS: We conducted a convergent mixed-methods study using cross-sectional quantitative data from the 2016 Nepal Demographic and Health Survey and primary data collected via 35 in-depth interviews and eight focus group discussions with 1000-day women and their family members, female community health volunteers (FCHVs) and health facility staff in two geographies of Nepal, Kaligandaki and Chapakot. Quantitative data were analysed using logistic regression and qualitative data using deductive coding. The results were triangulated and thematically organised according to the socio-ecological model (SEM). RESULTS: Facilitators and barriers emerged across individual, interpersonal and community levels of the SEM. In the survey, women with more children under five years of age, living in a male-headed household, or in rural areas had increased odds of HMG participation (p < 0.05) while belonging to the Janajati caste was associated with lower odds of participation (p < 0.05). Qualitative data helped to explain the findings. For instance, the quantitative analysis found women's education level associated with HMG participation (p < 0.05) while the qualitative analysis showed different ways women's education level could facilitate or hinder participation. Qualitative interviews further revealed that participation was facilitated by women's interest in acquiring new knowledge, having advanced awareness of the meeting schedule and venue, and engagement with health workers or non-government organisation staff. Participation was hindered by the lack of meeting structure and work obligations during the agricultural season. CONCLUSIONS: To improve women's participation in HMGs in Nepal, it is necessary to address factors at the SEM's individual, interpersonal, and community levels, such as enhancing FCHV literacy, providing advance notice of the meeting schedule, upgrading the meeting venues and reducing women's workload through family support, particularly during agricultural season. These improvements are essential for strengthening effective implementation of HMG meetings and similar women's group-based platforms, and for ultimately improving maternal and child health in Nepal.

Strengthening causal inference from randomised controlled trials of complex interventions.

Researchers conducting randomised controlled trials (RCTs) of complex interventions face design and analytical challenges that are not fully addressed in existing guidelines. Further guidance is needed to help ensure that these trials of complex interventions are conducted to the highest scientific standards while maximising the evidence that can be extracted from each trial. The key challenge is how to manage the multiplicity of outcomes required for the trial while minimising false positive and false negative findings. To address this challenge, we formulate three principles to conduct RCTs: (1) outcomes chosen should be driven by the intent and programme theory of the intervention and should thus be linked to testable hypotheses; (2) outcomes should be adequately powered and (3) researchers must be explicit and fully transparent about all outcomes and hypotheses before the trial is started and when the results are reported. Multiplicity in trials of complex interventions should be managed through careful planning and interpretation rather than through post hoc analytical adjustment. For trials of complex interventions, the distinction between primary and secondary outcomes as defined in current guidelines does not adequately protect against false positive and negative findings. Primary outcomes should be defined as outcomes that are relevant based on the intervention intent and programme theory, declared (ie, registered), and adequately powered. The possibility of confirmatory causal inference is limited to these outcomes. All other outcomes (either undeclared and/or inadequately powered) are secondary and inference relative to these outcomes will be exploratory.

Turned Away and at Risk: Denial of Family Planning Services to Women in Malawi.

Family planning (FP) has been a development priority since the mid-1990s, yet barriers to access persist globally, including women being turned away from facilities without a method. This study aimed to assess the extent of, and reasons for, FP turnaway in three districts of Malawi. In 2019, data collectors screened women exiting 30 health facilities and surveyed those who had been denied a method. Follow-up surveys were conducted via telephone with turned away clients at six and 12 weeks postvisit. Of the 2,246 women who were screened, 562 were new or restarting users. Of these, 15% (83/562) reported having been turned away from the health facility without an FP method. Women cited 14 different reasons for turnaway; the top three were unavailability of method (34%), unavailability of a provider (17%), or a requirement to return on the scheduled FP day (15%). The multiple reasons cited for leaving the health facility without an FP method indicate that reducing turnaway will not be achieved easily. The top reasons for turnaway are related to health systems or management issues within health facilities. Facilities need additional support for staffing, training on long-acting and permanent methods, and a consistent supply of methods.

The Provider Role and Perspective in the Denial of Family Planning Services to Women in Malawi: A Mixed-Methods Study.

Family planning (FP) has been a global health priority for decades, yet barriers persist, including women being turned away from facilities without receiving services. This study assessed the provider role and perspective in client turnaway in three districts of Malawi. In 2019, data collectors surveyed 57 FP providers from 30 health facilities. All reported being comfortable providing FP to married women with children and married adolescents under 18 years old with children, whereas 12% of the providers expressed discomfort providing such services to married adolescents under 18 without children. Sixty percent of the providers required clients desiring FP and wishing to initiate oral contraceptives or injectables to be currently menstruating. Data collectors later conducted in-depth interviews (IDIs) with 8 of the 57 providers about client turnaway. During IDIs, providers' most frequently mentioned reasons for turnaway was client pregnancy or suspicion of pregnancy. Providers expressed fears that initiating FP with a pregnant woman could cause community mistrust in the efficacy of modern contraception. Provider support for FP waned for nulliparous clients, regardless of age or marital status. To improve FP services in Malawi, providers need continuous education on all available methods of FP, a reduction in stockouts and programs to further sensitize the community to how contraception works. Understanding how Malawi has helped providers overcome social and cultural norms regarding provision of FP to adolescents might help other countries to make improvements.

Family Connections randomized controlled trial: assessing the feasibility and acceptability of an intervention with adolescents living with HIV and their caregivers in Ndola, Zambia.

Achieving the 95-95-95 UNAIDS targets requires meeting the needs of adolescents, however we lack evidenced-based approaches to improving adolescent adherence to antiretroviral therapy (ART), increasing viral suppression, and supporting general wellbeing. We developed Family Connections as a group intervention for adolescents and their adult caregivers and conducted a randomized controlled trial in Ndola, Zambia to test feasibility and acceptability. Fifty pairs (n = 100) of adolescents (15-19 years and on ART ≥ 6 months) and their caregivers were randomly assigned either to the intervention consisting of 10 group sessions over 6 months, or to a comparison group, which received the usual care. Each pair completed baseline and endline surveys, with adolescents also undergoing viral load testing. Of the 24-intervention adolescent/caregiver pairs, 88% attended at least eight group sessions. Most adolescents (96%) and all caregivers would recommend Family Connections to peers. Adolescent viral failure decreased but did not significantly differ by study group. Adolescents in the intervention group showed a greater reduction in HIV-related feelings of worthlessness and shame than the comparison group. The feasibility, acceptability, and the positive trend toward significantly reducing internalized stigma, generated by this Family Connections pilot study, contributes valuable data to support adolescent/caregiver approaches that use peer groups.

Improved HIV case finding among key populations after differentiated data driven community testing approaches in Zambia.

INTRODUCTION: Open Doors, an HIV prevention project targeting key populations in Zambia, recorded low HIV positivity rates (9%) among HIV testing clients, compared to national adult prevalence (12.3%), suggesting case finding efficiency could be improved. To close this gap, they undertook a series of targeted programmatic and management interventions. We share the outcomes of these interventions, specifically changes in testing volume, HIV positivity rate, and total numbers of key populations living with HIV identified. METHODS: The project implemented a range of interventions to improve HIV case finding using a Total Quality Leadership and Accountability (TQLA) approach. We analyzed program data for key populations who received HIV testing six months before the interventions (October 2017-March 2018) and 12 months after (April 2018-March 2019). Interrupted time series analysis was used to evaluate the impact on HIV positivity and total case finding and trends in positivity and case finding over time, before and after the interventions. RESULTS: While the monthly average number of HIV tests performed increased by only 14% post-intervention, the monthly average number of HIV positive individuals identified increased by 290%. The average HIV positivity rate rose from 9.7% to 32.4%. Positivity rates and case finding remained significantly higher in all post-intervention months. Similar trends were observed among FSW and MSM. CONCLUSIONS: The Open Doors project was able to reach large numbers of previously undiagnosed key populations by implementing a targeted managerial and technical intervention, resulting in a significant increase in the HIV positivity rate sustained over 12 months. These results demonstrate that differentiated, data-driven approaches can help close the 95-95-95 gaps among key populations.

Expanding long-acting contraceptive options: a prospective cohort study of the hormonal intrauterine device, copper intrauterine device, and implants in Nigeria and Zambia.

BACKGROUND: 30 years after the introduction of the levonorgestrel-releasing intrauterine device in Europe, several sub-Saharan African countries are seeking to broaden access to this contraceptive method. In this study, we aimed to assess 12-month continuation of the hormonal intrauterine device, copper intrauterine device, and implants, as well as to assess women's experiences and satisfaction using these methods in the private sector in Nigeria and the public sector in Zambia. METHODS: We did a prospective cohort study of long-acting reversible contraceptive users across 40 private sector clinics in Nigeria and 21 public sector clinics in Zambia. Eligible women were aged 18-49 years in Nigeria and 16-49 years in Zambia, had chosen to receive the hormonal intrauterine device, copper intrauterine device, or implant (either a 5-year levonorgestrel-releasing subdermal implant or a 3-year etonogestrel-releasing subdermal implant), and, in Nigeria only, had access to a telephone. Women were interviewed within 100 days of receiving their contraceptive method either via telephone in Nigeria or in person in Zambia, with follow-up surveys at 6 months and 12 months. The primary outcomes were method-specific, 12-month continuation rates-ie, continuation rates of the hormonal intrauterine device, copper intrauterine device, and implant across Nigeria and Zambia. We used Kaplan-Meier methods to estimate the cumulative probabilities of method-specific continuation and a log-rank test to compare contraceptive methods. We analysed self-reported satisfaction and experiences as a secondary outcome. FINDINGS: Between June 25 and Nov 22, 2018, we enrolled a total of 1542 women (n=860 in Nigeria and n=682 in Zambia) receiving a long-acting reversible contraceptive. In total, 835 women (266 [32%] hormonal intrauterine device users, 274 [33%] copper intrauterine device users, and 295 [35%] implant users) in Nigeria and 367 (140 [38%] hormonal intrauterine device users, 149 [40%] copper intrauterine device users, and 78 [21%] implant users) in Zambia were included in the study analysis. The 12-month cumulative continuation rates were 86·8% (95% CI 82·1-90·4) for the hormonal intrauterine device, 86·9% (82·1-90·4) for the copper intrauterine device, and 85·0% (80·2-88·7) for implants in Nigeria. In Zambia, the 12-month cumulative continuation rates were 94·7% (89·2-97·4) for the hormonal intrauterine device, 89·1% (82·3-93·4) for the copper intrauterine device, and 83·1% (72·2-90·1) for implants. At least 71% of respondents across the timepoints were very satisfied with their method, and at least 55 (79%) of 70 reported having recommended their contraceptive method to someone else. Across the methods, the most commonly self-reported positive aspect of long-acting reversible contraceptive use at 12 months was effectiveness in Nigeria (range 93-94%) and long-lasting duration in Zambia (48-60%). Between 124 (50%) of 248 and 136 (59%) of 230 Nigerian participants and 26 (42%) of 62 and 66 (57%) of 117 Zambian participants reported nothing negative about their contraceptive method. INTERPRETATION: Our study showed high continuation rates and satisfaction across long-acting reversible contraceptives, including the hormonal intrauterine device, a method that has been largely underused in sub-Saharan Africa. This finding supports the inclusion of the hormonal intrauterine device as a valuable addition to the mix of contraceptive methods in Nigeria and Zambia. FUNDING: Bill & Melinda Gates Foundation.

Optimizing the design of a contraceptive microarray patch: a discrete choice experiment on women's preferences in India and Nigeria.

BACKGROUND: Efforts are underway to develop an easy-to-use contraceptive microarray patch (MAP) that could expand the range of self-administrable methods. This paper presents results from a discrete choice experiment (DCE) designed to support optimal product design. METHODS: We conducted a DCE survey of users and non-users of contraception in New Delhi, India (496 women) and Ibadan, Nigeria (two versions with 530 and 416 women, respectively) to assess stated preferences for up to six potential product attributes: effect on menstruation, duration of effectiveness, application pain, location, rash after application, and patch size. We estimated Hierarchical Bayes coefficients (utilities) for each attribute level and ran simulations comparing women's preferences for hypothetical MAPs with varying attribute combinations. RESULTS: The most important attributes of the MAP were potential for menstrual side effects (55% of preferences in India and 42% in Nigeria) and duration (13% of preferences in India and 24% in Nigeria). Women preferred a regular period over an irregular or no period, and a six-month duration to three or one month. Simulations show that the most ideal design would be a small patch, providing 6 months of protection, that would involve no pain on administration, result in a one-day rash, and be applied to the foot. CONCLUSIONS: To the extent possible, MAP developers should consider method designs and formulations that limit menstrual side effects and provide more than one month of protection.

Task Sharing of Injectable Contraception Services in Pakistan: A Randomized Controlled Trial.

Provision of injectable contraceptive services by lay health workers is endorsed by normative bodies, but support for this practice is not universal. We assessed whether lay providers (lady health workers, LHWs) could perform as well as clinically trained providers (family welfare workers, FWWs) on appropriate screening, counseling, and injection of intramuscular and subcutaneous depot medroxyprogesterone acetate (DMPA) using a randomized controlled trial. In the urban sample (n = 355), 88 percent of FWW DMPA clients were appropriately screened versus 77 percent of LHW clients (noninferiority test p = 0.88). In rural facilities (n = 105), over 90 percent of both providers' clients were screened appropriately. Appropriate counseling was low overall, but LHWs were significantly noninferior to FWWs (p = 0.003). Notably, LHWs demonstrated better injection technique than FWWs. We could not conclude that LHWs screened new DMPA users as well as FWWs from an urban sample of providers but results from the rural sample suggests that service delivery context played an important role.

Correlates of uptake of HIV testing among children and young adolescents in Akwa-Ibom state, Nigeria: a secondary data analysis of the Akwa-Ibom aids indicator survey, 2017.

BACKGROUND: In order to end the AIDS epidemic by 2030, there is a need to significantly reduce the rate of new infection among children and young adolescents. Identifying the correlates of testing behaviour is necessary to improve HIV testing campaigns by refining messages that target individuals in this age group. The objective of this study was to determine the correlates of HIV testing among children and young adolescents in Akwa-Ibom, Nigeria. METHODS: The outcome was a secondary data analysis of the 2017 Akwa-Ibom AIDS Indicator Survey. Data of 4037 children and young adolescents aged 0-14 years was assessed in this study. Analysis was done using STATA version 16. Chi-squared test and logistic regression models were used to measure association and its strength between uptake of HIV testing and some independent variables (child/caregiver's age, sex, educational status, child's location, caregiver's knowledge of HIV and caregiver ever tested for HIV) at 5% significance level. RESULTS: Result showed that only 14.2% of the children and young adolescents have been tested for HIV. Previous history of blood transfusion (AOR = 5.33, 95%C.I = 2.60-10.92, P = < 0.001), caregiver's level of education (AOR = 2.67, 95%C.I = 1.30-5.51, P = 0.008) and caregiver ever tested for HIV (AOR = 8.31, 95%C.I = 5.67-12.19, P = < 0.001) were significantly associated with uptake of HIV testing. CONCLUSION: This study concludes that a large proportion of children and young adolescents in Akwa-Ibom state have never been tested for HIV. There is a need for HIV testing interventions to be targeted towards this age groups and their parents/guardian. Addressing the knowledge gap amongst caregivers especially in rural areas is crucial towards improving the effectiveness of HIV testing interventions.

How Much Do Side Effects Contribute to Discontinuation? A Longitudinal Study of IUD and Implant Users in Senegal.

INTRODUCTION: In Senegal, discontinuation due to sides effects of long-acting, reversible contraceptives (LARCs) is relatively low; 5% of new implant acceptors and 11% of new IUD acceptors stop using in their first year because of health or side effect concerns. This study investigated factors associated with LARC discontinuation in the first 12 months of use in Senegal and explored how LARC users cope with side effects. METHODS: This mixed-method study involved quantitative interviews at five time points with LARC acceptors recruited from three service channels between February 2018 and March 2019. Qualitative interviews were conducted in August 2018 with a subset of those who experienced side effects. Logistic regression models identified factors associated with discontinuation due to side effects and discontinuation for any reason. Twelve-month discontinuation rates due to side effects were also estimated using a cumulative incidence function (CIF) approach to account for time to discontinuation. RESULTS: In logistic models, method choice (IUD or implant) [OR = 3.15 (95% CI: 1.91-5.22)] and parity [OR = 0.81 (95% CI: 0.7-0.94)] were associated with discontinuation due to side effects; IUD users and women with fewer children were more likely to discontinue. Results for all-cause discontinuation were similar: method choice [OR = 2.39 (95% CI: 1.6-3.58)] and parity [OR = 0.86 (95% CI: 0.77-0.96)] were significant predictors. The 12-month side effect CIF discontinuation rate was 11.2% (95% CI: 7.9-15.0%) for IUDs and 4.9% (95% CI: 3.5-6.6%) for implants. Side effect experiences varied, but most women considered menstrual changes the least acceptable. No statistically significant differences across services channels were observed. CONCLUSIONS: In this study in Senegal, the choice between implants and IUDs had a significant impact on continuation, and women with more children continued LARC methods longer, despite side effects.

Exploring the Use of Mobile Health to Improve Community-Based Health and Nutrition Service Utilization in the Hills of Nepal: Qualitative Study.

BACKGROUND: With mobile phone coverage and ownership expanding globally, mobile health (mHealth) interventions are increasingly being used to improve coverage and quality of health and nutrition services. However, evidence on mHealth intervention feasibility and factors to consider during program design is limited in low- and middle-income countries like Nepal. OBJECTIVE: This study aimed to examine the potential of using text messages to improve health and nutrition services by exploring mobile phone ownership and sharing; mobile phone use and skills; and interest, preferences, and limitations regarding mHealth interventions. METHODS: We conducted 35 in-depth interviews with 1000-day women (the period from conception to a child's second birthday), health facility staff, and female community health volunteers (FCHVs), as well as eight focus group discussions with health facility staff, FCHVs, and 1000-day household decision-makers (ie, husbands, mothers-in-law, and fathers-in-law). We also conducted a mobile phone skills test. We employed thematic analysis using framework matrices and analytical memos. RESULTS: The study included 70 study participants, of whom 68 (97%) had a mobile phone, and phone sharing was uncommon. Use of text messages was most commonly reported by 1000-day women and health facility staff than household decision-makers and FCHVs. More than 8 in 10 participants (54/64, 84%) could dial numbers, and the majority (28/34, 82%) of 1000-day women, health facility staff, and male decision-makers could also read and write text messages. We found that 1000-day women preferred educational and reminder messages, whereas health facility staff and FCHVs desired educational and motivational messages. Participants suggested different types of texts for 1000-day women, families, FCHVs, and health facility staff, and reported less value for texts received from unknown phone numbers. CONCLUSIONS: A text message-based mHealth intervention is acceptable in the hills of Nepal and has the potential to improve community health and nutrition service utilization, particularly by sending meeting reminders and by providing information. Our findings contribute to text message-based mHealth intervention design in under-resourced settings.

What Goes In Must Come Out: A Mixed-Method Study of Access to Contraceptive Implant Removal Services in Ghana.

BACKGROUND: Access to quality removal services is a key component of informed choice in contraceptive implant use; however, limited data exist on users' access to removal services. In Ghana, implants are available across the country and are the most commonly used contraceptive method among married women. METHODS: From October 2017 and January 2018, we conducted a phone survey with a stratified random sample of 1,159 women who had obtained an implant from a public-sector Ghana Health Service clinic in 2 regions and 1,073 women who had an implant inserted through Marie Stopes International Ghana (MSIG) mobile outreach in 2 other regions. We also interviewed 50 women just after receiving an implant removal from MSIG. We conducted follow-up in-depth interviews with 20 implant acceptors and 15 implant providers across the 4 study regions. RESULTS: More than four-fifths of women in both service delivery contexts knew that their implant could be removed before its labeled duration. Nearly half of public sector clients and one-third of outreach clients reported that their provider only told them of removal access at the place of insertion. Among women obtaining their implant in the public and outreach sectors, respectively, 32% and 21% reported ever wanting it removed and 61% and 55% who attempted removal obtained a removal on the first attempt. An additional 17% in each context were successful in having their implant removed within 1 week of the first attempt. Most women obtained removal from the same place they received their insertion (81% public, 70% outreach). Most women reported their overall removal experience was very or somewhat easy (74% public, 68% outreach). Challenges included cost, provider availability, interactions with providers, and difficult removals. CONCLUSIONS: Access to implant removal is not universal in Ghana. Strengthening removal services in both the public and outreach sectors is needed to ensure comprehensive access.

A Social Media-Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial.

BACKGROUND: Youth living with HIV (YLHIV) enrolled in HIV treatment experience higher loss to follow-up, suboptimal treatment adherence, and greater HIV-related mortality compared with younger children or adults. Despite poorer health outcomes, few interventions target youth specifically. Expanding access to mobile phone technology, in low- and middle-income countries (LMICs) in particular, has increased interest in using this technology to improve health outcomes. mHealth interventions may present innovative opportunities to improve adherence and retention among YLHIV in LMICs. OBJECTIVE: This study aimed to test the effectiveness of a structured support group intervention, Social Media to promote Adherence and Retention in Treatment (SMART) Connections, delivered through a social media platform, on HIV treatment retention among YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support. METHODS: We conducted a parallel, unblinded randomized controlled trial. YLHIV enrolled in HIV treatment for less than 12 months were randomized in a 1:1 ratio to receive SMART Connections (intervention) or standard of care alone (control). We collected data at baseline and endline through structured interviews and medical record extraction. We also conducted in-depth interviews with subsets of intervention group participants. The primary outcome was retention in HIV treatment. We conducted a time-to-event analysis examining time retained in treatment from study enrollment to the date the participant was no longer classified as active-on-treatment. RESULTS: A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172). Our primary analysis included data from 324 participants at endline. The probability of being retained in treatment did not differ significantly between the 2 study arms during the study. Retention was high at endline, with 75.7% (112/163) of intervention group participants and 83.4% (126/161) of control group participants active on treatment. HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support. Intervention group participants overwhelmingly reported that the intervention was useful, that they enjoyed taking part, and that they would recommend it to other YLHIV. CONCLUSIONS: Our findings of improved HIV knowledge and high acceptability are encouraging, despite a lack of measurable effect on retention. Retention was greater than anticipated in both groups, likely a result of external efforts that began partway through the study. Qualitative data indicate that the SMART Connections intervention may have contributed to retention, adherence, and social support in ways that were not captured quantitatively. Web-based delivery of support group interventions can permit people to access information and other group members privately, when convenient, and without travel. Such digital health interventions may help fill critical gaps in services available for YLHIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT03516318; https://clinicaltrials.gov/ct2/show/NCT03516318.

Factors associated with reported modern contraceptive use among married men in Afghanistan.

BACKGROUND: Afghanistan has high maternal and infant mortality which is in part driven by high fertility and low modern contraceptive use. Using modern contraceptive methods can reduce maternal and infant mortality, however there are several barriers to modern contraceptive use in Afghanistan. Married men have the potential to hinder or facilitate their wives' contraceptive use. Internally displaced persons (IDP), a growing population in Afghanistan, are rarely included in reproductive health research. We explored whether married men's, including IDPs', gender-related attitudes and other factors were associated with reported modern contraceptive use to inform programming to meet reproductive health needs of married couples. METHODS: Cross-sectional study using data from 885 married men determined to have contraceptive need in seven Afghan provinces. We explored associations between sociodemographic factors, IDP status, wives' involvement in household decision-making and men's attitudes towards intimate partner violence (IPV) with reported modern contraceptive use using logistic regression analysis. RESULTS: Most men (78%) had ≥2 children, 60% reported any formal education, and 30% reported being IDPs. Only 38% of married men and 24% of IDPs with contraceptive need reported using modern contraception with their wives. Most (80% overall, 63% of IDPs) reported their wives' involvement in some/all household decisions, while 47% overall and 57% of IDPs reported IPV was justified in one or more listed circumstances. In bivariate analysis, men responding that IPV was not justified in any listed circumstance were more likely and IDPs less likely to report modern contraceptive use. In multivariable analysis, involvement by wives in household decision-making (AOR 2.57; 95% CI: 1.51, 4.37), owning a radio and/or television (AOR 1.69; 95% CI: 1.10, 2.59), having more children, age, and province of interview were independently associated with reported modern contraceptive use, while IDP status was not. CONCLUSIONS: Our findings reflect positive associations between wives' participation in household decisions and mass media exposure (television/radio ownership) with reported modern contraceptive use. Reproductive health initiatives engaging men to promote communication within couples and through mass media channels may further increase modern contraceptive use and advance Afghanistan's family planning goals. As fewer IDPs owned a radio/television, additional outreach methods should be tested for this group.

The effects of the integration of an economic strengthening and HIV prevention education programme on the prevalence of sexually transmitted infections and savings behaviours among adolescents: a full-factorial randomised controlled trial in South Africa.

Background: Multisectoral approaches are thought necessary to prevent HIV among adolescents. We examined whether an economic strengthening (ES) and an HIV-prevention education intervention improved outcomes when combined versus separately. Methods: We conducted a full-factorial randomised controlled study to randomise participants into all possible intervention groups based on the two interventions: economic strengthening only (ES-only), HIV-prevention only (HIV-only), both interventions combined (ES+HIV) and no intervention (control). We measured sexually transmitted infections (STIs), self-reported economic and sexual behaviours/knowledge, and pregnancy at a pre-intervention and two post-intervention assessments. Eligible participants were adolescents 14 to 17 years old from a programme supporting vulnerable families in Gauteng Province, South Africa. We estimated intervention effects using repeated measures, generalised linear mixed models. Results: A total of 1773 adolescents participated (57% female). ES+HIV adolescents had the lowest STI prevalence at first endline; however, the comparison with the control was not significant (OR 0.62, 95% CI 0.27 to 1.41). ES-only or HIV-only groups were not significantly better than the control on STI prevalence (OR 1.53, 95% CI 0.73 to 3.20 and OR 1.47, 95% CI 0.69 to 3.12, respectively). STI prevalence became more similar among the groups at second endline.ES-only adolescents were more likely to participate in savings groups (p=0.004) and plan to save for education (p=0.001) versus the control. ES+HIV adolescents were more likely to plan to save for education versus the control (p=0.001) and HIV-only groups (p=0.002) but did not differ significantly from the ES-only group (p=0.803). The ES+HIV intervention's effect on HIV knowledge was significant compared with the control (p=0.03) and ES-only groups (p<0.001), but not when compared with the HIV-only group (p=0.091). Effects on pregnancy, sexual behaviours or other economic behaviours were not significant. Conclusions: We could not confirm the ES and HIV interventions, separately or combined, were effective to reduce STI prevalence. Evaluations of multicomponent interventions should use full-factorial designs to fully assess effects. Trial registration number: NCT02888678.

A simple method to assess and report thematic saturation in qualitative research.

Data saturation is the most commonly employed concept for estimating sample sizes in qualitative research. Over the past 20 years, scholars using both empirical research and mathematical/statistical models have made significant contributions to the question: How many qualitative interviews are enough? This body of work has advanced the evidence base for sample size estimation in qualitative inquiry during the design phase of a study, prior to data collection, but it does not provide qualitative researchers with a simple and reliable way to determine the adequacy of sample sizes during and/or after data collection. Using the principle of saturation as a foundation, we describe and validate a simple-to-apply method for assessing and reporting on saturation in the context of inductive thematic analyses. Following a review of the empirical research on data saturation and sample size estimation in qualitative research, we propose an alternative way to evaluate saturation that overcomes the shortcomings and challenges associated with existing methods identified in our review. Our approach includes three primary elements in its calculation and assessment: Base Size, Run Length, and New Information Threshold. We additionally propose a more flexible approach to reporting saturation. To validate our method, we use a bootstrapping technique on three existing thematically coded qualitative datasets generated from in-depth interviews. Results from this analysis indicate the method we propose to assess and report on saturation is feasible and congruent with findings from earlier studies.

Young Women's Experiences With Subcutaneous Depot Medroxyprogesterone Acetate: A Secondary Analysis of a One-Year Randomized Trial in Malawi.

PURPOSE: The purpose of this study was to compare the effectiveness, safety, and experiences with side effects of self-injected and provider-administered injectable contraception between young (18-24 years) versus older (≥25 years) women. METHODS: We conducted secondary analysis of data from a 12-month randomized controlled trial in Malawi, where a total of 731 women were randomized to receive subcutaneous depot medroxyprogesterone acetate (DMPA-SC) administered by a provider or be trained to self-inject subcutaneous depot medroxyprogesterone acetate. Data collectors contacted women after the reinjection window at 3, 6, and 9 months to collect data on discontinuation and women's experiences, including adverse events. Twelve months after enrollment or at early discontinuation, women had their final interview, including pregnancy testing. We compared continuation, pregnancy, safety, and side effects among young women versus older women. RESULTS: Among self-injectors, there were no significant differences found in continuation by age (p = .345) with continuation rates at 12 months of 79% for young women and 69% for older women. Continuation rates were lower for both age groups with provider-administered injections. In the provider-administered group, continuation rates among young women (39%) were lower than among older women (49%) (p = .047). The distribution of reasons for discontinuation did not differ significantly by age for those receiving provider injections (p = .698). However, younger self-injectors were less likely to miss the reinjection window than older self-injectors (p = .011). Age did not significantly influence pregnancy or safety. CONCLUSIONS: With evidence of potential higher impact on continuation and no safety concerns, we recommend self-injection be added to the contraception options available to young women in low-resource settings.