Mens adherence to constraining male gender norms can lead them to resist contraceptive use. Very few interventions have attempted to transform masculine norms to encourage greater contraceptive acceptance and gender equality. We designed and evaluated a small-scale community-based intervention targeting the masculine norms tied to contraceptive resistance among partnered men (N = 150) in two western Kenya communities (intervention vs. control). Pre-post survey data fit to linear and logistic regression models evaluated differences in post-intervention outcomes, accounting for pre-intervention differences. Intervention participation was associated with increases in contraceptive acceptance scores (adjusted coefficient (aβ) 1.04; 95% confidence interval (CI) 0.16, 1.91; p = 0.02) and contraceptive knowledge scores (aβ 0.22; 95% CI 0.13, 0.31; p < 0.001) and with contraceptive discussions with ones partner (adjusted Odds Ratio (aOR) 3.96; 95% CI 1.21, 12.94; p = 0.02) and with others (aOR 6.13; 95% CI 2.39, 15.73; p < 0.001). The intervention was not associated with contraceptive behavioural intention or use. Our findings demonstrate the promise of a masculinity-driven intervention on increasing mens contraceptive acceptance and positive contraceptive involvement. A larger randomised trial is needed to test the effectiveness of the intervention among men as well as among couples.

Male partner resistance is identified as a key factor that influences women's contraceptive use. Examination of the masculine norms that shape men's resistance to contraception-and how to intervene on these norms-is needed. To assess a gender-transformative intervention in Kenya, we developed and evaluated a masculinity-informed instrument to measure men's contraceptive acceptance-the Masculine Norms and Family Planning Acceptance (MNFPA) scale. We developed draft scale items based on qualitative research and administered them to partnered Kenyan men (n = 150). Item response theory-based methods were used to reduce and psychometrically evaluate final scale items. The MNFPA scale had a Cronbach's α of 0.68 and loaded onto a single factor. MNFPA scores were associated with self-efficacy and intention to accept a female partner's use of contraception; scores were not associated with current contraceptive use. The MNFPA scale is the first rigorously developed and psychometrically evaluated tool to assess men's contraceptive acceptance as a function of male gender norms. Future work is needed to test the MNFPA measure in larger samples and across different contexts. The scale can be used to evaluate interventions that seek to shift gender norms to increase men's positive engagement in pregnancy spacing and prevention.

Background

In recent years, safer conception strategies have been developed to help HIV-serodiscordant couples conceive a child without transmitting HIV to the seronegative partner. The SAFER clinical trial assessed implementation of these strategies in Zimbabwe.

Methods

As a part of the SAFER study, we estimated the costs (in 2017 $US) associated with individual and combination strategies, in the trial setting and real-world practice, from a healthcare system perspective. Safer conception strategies included: 1) ART with frequent viral load testing until achieving undetectable viral load (ART-VL); 2) daily oral pre-exposure prophylaxis (PrEP); 3) semen-washing with intrauterine insemination; and 4) manual self-insemination at home. For costs in the trial, we used a micro-costing approach, including a time and motion study to quantify personnel effort, and estimated the cost per couple for individual and combination strategies for a mean of 6 months of safer services. For real-world practice, we modeled costs for three implementation scenarios, representing differences from the trial in input prices (paid by the Ministry of Health and Child Care [MOHCC]), intervention intensity, and increments to current HIV prevention and treatment practices and guidelines. We used one-way sensitivity analyses to assess the impact of uncertainty in input variables.

Results

Individual strategy costs were $769-$1615 per couple in the trial; $185-$563 if using MOHCC prices. Under the target intervention intensity and using MOHCC prices, individual strategy costs were $73-$360 per couple over and above the cost of current HIV clinical practices. The cost of delivering the most commonly selected combination, ART-VL plus PrEP, ranged from $166-$517 per couple under the three real-world scenarios. Highest costs were for personnel, lab tests, and strategy-specific consumables, in variable proportions by clinical strategy and analysis scenario. Total costs were most affected by uncertainty in the price of PrEP, number of semen-washing attempts, and scale-up of semen-washing capacity.

Conclusions

Safer conception methods have costs that may be affordable in many low-resource settings. These cost data will help implementers and policymakers add safer conception services. Cost-effectiveness analysis is needed to assess value for money for safer conception services overall and for safer strategy combinations.

Trial registration

Registry Name: Clinicaltrials.gov.

Trial registration number

NCT03049176 . Registration date: February 9, 2017.

Much of the methodological literature on rapid qualitative analysis describes processes used by a relatively small number of researchers focusing on one study site and using rapid analysis to replace a traditional analytical approach. In this paper, we describe the experiences of a transnational research consortium integrating both rapid and traditional qualitative analysis approaches to develop social theory while also informing program design. Research was conducted by the Innovations for Choice and Autonomy (ICAN) consortium, which seeks to understand how self-injection of the contraceptive subcutaneous depot medroxyprogesterone acetate (DMPA-SC) can be implemented in a way that best meets women's needs, as defined by women themselves. Consortium members are based in Kenya, Uganda, Malawi, Nigeria, and the United States. Data for the ICAN study was collected in all four countries in sub-Saharan Africa. In order to both illuminate social phenomena across study sites and inform the program design component of the study, researchers developed tools meant to gather both in-depth information about women's contraceptive decision-making and data targeted specifically to program design during the formative qualitative phase of the study. Using these two bodies of data, researchers then simultaneously conducted both a traditional qualitative and rapid analysis to meet multiple study objectives. To complete the traditional analysis, researchers coded interview transcripts and kept analytical memos, while also drawing on data collected by tools developed for the rapid analysis. Rapid analysis consisted of simultaneously collecting data and reviewing notes developed specifically for this analysis. We conclude that integrating traditional and rapid qualitative analysis enabled us to meet the needs of a complex transnational study with the added benefit of grounding our program design work in more robust primary data than normally is available for studies using a human-centered design approach to intervention development. However, the realities of conducting a multi-faceted study across multiple countries and contexts made truly "rapid" analysis challenging.

Safer conception services are needed to minimize HIV transmission among HIV sero-different couples desiring pregnancy. Few studies have evaluated the choices couples make when offered multiple safer conception methods or real-world method acceptability and effectiveness. We piloted a comprehensive safer conception program (Clintrials.gov identifier: NCT03049176) for HIV sero-different couples planning pregnancy in Zimbabwe to measure feasibility, method uptake, acceptability, pregnancy outcome, and HIV transmission. This study was not designed to compare rates of HIV transmission by safer conception method choice but rather to understand choices couples make when seeking to minimize risk of HIV transmission and maximize likelihood of pregnancy. Couples in this prospective, non-randomized study were given a choice of one or more currently available safer conception methods: antiretroviral therapy (ART) with monthly viral load (VL) monitoring for the HIV-positive partner (ART/VL), pre-exposure prophylaxis (PrEP) for the HIV-negative partner, vaginal insemination (VI) for couples with an HIV-positive woman, and semen washing (SW) for couples with an HIV-positive man. Couples were followed monthly for up to 12 months of pregnancy attempts, quarterly during pregnancy, and 12 weeks post-partum. At each visit, data on method use, urine for pregnancy testing, and blood for HIV antibody testing, or viral load if HIV-positive, were obtained. Infants born to HIV-positive women were tested for HIV at 6 and 12 weeks. Between March 2017 and June 2019, 46 individuals from 23 HIV sero-different partnerships were enrolled and followed. At enrollment, all couples chose ART/VL, and all couples chose at least one additional method; 74% chose PrEP, 36% chose SW, and 25% chose VI. During pre-pregnancy follow-up visits, three couples discontinued SW, and one couple discontinued VI; all four of these couples opted for ART/VL plus PrEP. Satisfaction with safer conception methods was high among those who chose ART/VL and PrEP. Twelve couples achieved pregnancy. There were no cases of HIV transmission to partners, and no infants tested positive for HIV. This safer conception program is feasible and acceptable, allowing sero-different couples to safely achieve pregnancy. Sero-different couples in Zimbabwe seek a combination of HIV prevention methods, particularly ART/VL plus PrEP. Trial Registration: Clintrials.gov, NCT03049176.

Decision-making on childbearing and safer conception use in HIV sero-different couples involves an intricate balance of individual desires and perceived HIV acquisition risk. This paper addresses an important knowledge gap regarding HIV sero-different couples considerations and the relationship and power dynamics involved when deciding to use a safer conception method. Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples, who exited the SAFER study - a pilot study assessing the feasibility, acceptability and cost-effectiveness of a safer conception programme for HIV sero-different couples in Zimbabwe. All couples in SAFER were provided with a choice of safer conception methods and were followed for up to 12 months of pregnancy attempts and 3 months following pregnancy. While couples generally perceived their safer conception discussions to be easy and consensus-driven, the decision-making process also involved complex gender dynamics and trade-offs in relationship power, which resulted in differing interpretations of what constituted a joint or shared couple decision. Participants regarded effective couple communication as an essential component of and precursor to good safer conception conversations and requested additional training in couple communication. Couples relied on information from healthcare providers to kickstart their safer conception discussions. Safer conception programmes should address relationship power imbalances, promote effective couple communication and offer healthcare provider support to enable HIV sero-different couples to make informed choices about conception in a manner that upholds their safety and reproductive autonomy.

BACKGROUND: Safer conception services are needed to minimize HIV transmission among HIV sero-discordant couples desiring pregnancy. Few studies have evaluated the choices couples make when they are offered multiple safer conception methods or real-world method acceptability. This paper addresses an important knowledge gap regarding factors that influence the choice of safer conception methods, couples actual experiences using safer conception methods, and why some couples switch safer conception methods. METHODS: Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples who exited the SAFER study-a pilot safer conception study for HIV sero-discordant couples in Zimbabwe that offered couples a choice of ART with monthly viral load monitoring (ART/VL), oral PrEP, vaginal insemination, and semen washing. All couples in SAFER had used at least two safer conception methods. RESULTS: We found that safer conception method choice often centered around a desire for intimacy, condomless sex, and certainty in the conception process, particularly for men. Method-related attributes such as familiarity, perceived ease of use, side effects, and perceived level of effectiveness in preventing HIV and achieving pregnancy influenced method choice, switching, and satisfaction. Concerns were expressed about each safer conception method and couples were willing to try different methods until they found method(s) that worked for them. The majority of participants reported having positive experiences using safer conception, especially those using ART/VL + PrEP, citing that they were able to attempt pregnancy for the first time with peace of mind and experienced joy and satisfaction from being able to achieve pregnancy safely. CONCLUSIONS: The differences in method preferences and experiences voiced by participants in this study and in other studies from the region point to the importance of having a variety of safer conception options in the service delivery package and addressing concerns about paternity, intimacy, and method-related attributes to enable HIV sero-discordant couples to safely achieve their reproductive goals.