A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, "Strengthening Our Vows": Study protocol and baseline data.

BACKGROUND: Heterosexual couples contribute to most new HIV infections in areas of generalized HIV epidemics in sub-Saharan Africa. After Couples' Voluntary HIV Counseling and Testing (CVCT), heterosexual concordant HIV negative couples (CNC) in cohabiting unions contribute to approximately 47% of residual new infections in couples. These infections are attributed to concurrent sexual partners, a key driver of the HIV epidemic in Zambia. METHODS/DESIGN: Ten Zambian government clinics in two of the largest cities were randomized in matched pairs to a Strengthening Our Vows (SOV) intervention or a Good Health Package (GHP) comparison arm. SOV addressed preventing HIV infection from concurrent partners and protecting spouses after exposures outside the relationship. GHP focused on handwashing; water chlorination; household deworming; and screening for hypertension, diabetes and schistosomiasis. CNC were referred from CVCT services in government clinics. Follow-up includes post-intervention questionnaires and outcome assessments through 60 months. Longitudinal outcomes of interest include self-report and laboratory markers of condomless sex with outside partners and reported sexual agreements. We present baseline characteristics and factors associated with study arm and reported risk using descriptive statistics. RESULTS: The mean age of men was 32 and 26 for women. On average, couples cohabited for 6 years and had 2 children. Baseline analyses demonstrated some failures of randomization by study arm which will be considered in future primary analyses of longitudinal data. An HIV/STI risk factor composite was not different in the two study arms. Almost one-quarter of couples had an HIV risk factor at baseline. DISCUSSION: In preparation for future biomedical and behavioral interventions in sub-Saharan Africa, it is critical to understand and decrease HIV risk within CNC.

Postpartum long-acting contraception uptake and service delivery outcomes after a multilevel intervention in Kigali, Rwanda.

INTRODUCTION: Postpartum family planning (PPFP) is critical to reduce maternal-child mortality, abortion and unintended pregnancy. As in most countries, the majority of PP women in Rwanda have an unmet need for PPFP. In particular, increasing use of the highly effective PP long-acting reversible contraceptive (LARC) methods (the intrauterine device (IUD) and implant) is a national priority. We developed a multilevel intervention to increase supply and demand for PPFP services in Kigali, Rwanda. METHODS: We implemented our intervention (which included PPFP promotional counselling for clients, training for providers, and Ministry of Health stakeholder involvement) in six government health facilities from August 2017 to October 2018. While increasing knowledge and uptake of the IUD was a primary objective, all contraceptive method options were discussed and made available. Here, we report a secondary analysis of PP implant uptake and present already published data on PPIUD uptake for reference. RESULTS: Over a 15-month implementation period, 12 068 women received PPFP educational counselling and delivered at a study facility. Of these women, 1252 chose a PP implant (10.4% uptake) and 3372 chose a PPIUD (27.9% uptake). On average providers at our intervention facilities inserted 83.5 PP implants/month and 224.8 PPIUDs/month. Prior to our intervention, 30 PP implants/month and 8 PPIUDs/month were inserted at our selected facilities. Providers reported high ease of LARC insertion, and clients reported minimal insertion anxiety and pain. CONCLUSIONS: PP implant and PPIUD uptake significantly increased after implementation of our multilevel intervention. PPFP methods were well received by clients and providers.

Cost-effectiveness of integrated HIV prevention and family planning services for Zambian couples.

OBJECTIVE: To present the incremental cost from the payer's perspective and effectiveness of couples' family planning counseling (CFPC) with long-acting reversible contraception (LARC) access integrated with couples' voluntary HIV counseling and testing (CVCT) in Zambia. This integrated program is evaluated incremental to existing individual HIV counseling and testing and family planning services. DESIGN: Implementation and modelling. SETTING: Fifty-five government health facilities in Zambia. SUBJECTS: Patients in government health facilities. INTERVENTION: Community health workers and personnel promoted and delivered integrated CVCT+CFPC from March 2013 to September 2015. MAIN OUTCOME MEASURES: We report financial costs of actual expenditures during integrated program implementation and outcomes of CVCT+CFPC uptake and LARC uptake. We model primary outcomes of cost-per-: adult HIV infections averted by CVCT, unintended pregnancies averted by LARC, couple-years of protection against unintended pregnancy by LARC, and perinatal HIV infections averted by LARC. Costs and outcomes were discounted at 3% per year. RESULTS: Integrated program costs were $3 582 186 (2015 USD), 82 231 couples received CVCT+CFPC, and 56 409 women received LARC insertions. The program averted an estimated 7165 adult HIV infections at $384 per adult HIV infection averted over a 5-year time horizon. The program also averted 62 265 unintended pregnancies and was cost-saving for measures of cost-per-unintended pregnancy averted, cost-per-couple-year of protection against unintended pregnancy, and cost-per-perinatal HIV infection averted assuming 3 years of LARC use. CONCLUSION: Our intervention was cost-savings for CFPC outcomes and CVCT was effective and affordable in Zambia. Integrated couples-focused HIV and family planning was feasible, affordable, and leveraged HIV and unintended pregnancy prevention.

A couple-focused, integrated unplanned pregnancy and HIV prevention program in urban and rural Zambia.

BACKGROUND: Zambia's total fertility rate (5 births per woman) and adult HIV prevalence (11.5%) are among the highest in the world, with heterosexual couples being the most affected group. Jointly counseling and testing couples for HIV has reduced up to 58% of new HIV infections in Zambian clinics. Married women using contraceptives in Zambia have a high (20%) unmet need for family planning and low (8.6%) uptake of cost-effective long-acting reversible contraceptives. We present an integrated counseling, testing, and family-planning program to prevent HIV and unplanned pregnancy in Zambia. OBJECTIVE: The objective of this study was to integrate effective HIV prevention and family-planning services for Zambian couples. STUDY DESIGN: A 3 year program (2013-2016) progressively integrated the promotion and provision of couples' voluntary HIV counseling and testing and long-acting reversible contraceptives. The program was based in 55 urban and 215 rural government clinics across 33 districts. In the first year, a couples' family-planning counseling training program was developed and combined with existing couples HIV counseling training materials. To avoid congestion during routine clinic hours, joint counseling services were initially provided on weekends, while nurses were trained in intrauterine device and hormonal implant insertion and removal during weekday family-planning services. Demand was created through mutual referral between weekend and weekday programs and by clinic staff, community health workers, and satisfied family-planning clients. When the bulk of integrated service training was completed, the program transitioned services to routine weekday clinic hours, ensuring access to same-day services. Performance indicators included number of staff trained, clients served, integrated service referrals, HIV infections averted, and unplanned pregnancies averted. RESULTS: A stepwise approach trained high-performing service providers to be trainers and used high-volume clinics for practicum training of the next generation. In total, 1201 (391 urban, 810 rural) counselors were trained and served 120,535 urban and 87,676 rural couples. In urban clinics, 236 nurses inserted 65,619 long-acting reversible contraceptives, while in rural clinics, 243 nurses inserted 35,703 implants and intrauterine devices. The program prevented an estimated 12,869 urban and 8279 rural adult HIV infections, and 98,626 unintended urban pregnancies. In the final year, the proportion of clients receiving joint counseling services on weekdays rose from 11% to 89%, with many referred from within clinics including HIV testing and treatment services (32%), outpatient department (31%), family planning (16%), and infant vaccination (15%). The largest group of clients requesting long-acting reversible contraceptives (45%) did so after joint fertility goal-based counseling, confirming the high impact of this couple-focused demand creation approach. Remaining family-planning clients responded to referrals from clinic nurses (34%), satisfied implant/intrauterine device users (13%), or community health workers (8%). CONCLUSION: Integrated HIV and unplanned pregnancy prevention can be implemented in low-resource public sector facilities. Combination services offered to couples mutually leverage HIV prevention and unplanned pregnancy prevention. The addition of long-acting reversible contraceptives is an important complement to the method mix available in government clinics. Demand creation in the clinic and in the community must be coordinated with a growing supply of well-trained providers.

An Exploratory Analysis of Factors Associated With Interest in Postpartum Intrauterine Device Uptake Among Pregnant Women and Couples in Kigali, Rwanda.

BACKGROUND: The desire to space or prevent future pregnancies is high among postpartum women in Rwanda. However, the use of long-acting reversible contraception (LARC), especially the highly effective and cost-effective copper intrauterine device (IUD), is very low, whereas the rates of unintended pregnancy are high. This study aims to identify factors associated with pregnant women's and couple's interest in receiving a postpartum intrauterine device (PPIUD) within 6 weeks after delivery. METHODS: A total of 150 pregnant women or couples attending antenatal care (ANC) in Kigali, Rwanda participated in this cross-sectional study. After participating in a postpartum LARC counseling session, surveys assessed participants' demographics, pregnancy experiences and desires, and PPIUD knowledge, attitudes, practices, and interest. Multivariable logistic regression was used to model factors associated PPIUD interest within 6 weeks postpartum. RESULTS: Although only 3% of women had ever used an IUD previously, 124 (83%) women were interested in receiving a PPIUD after counseling. Self-reporting physical side effects (adjusted odds ratio [aOR], 0.21; 95% confidence interval [CI], 0.06-0.75) and infection (aOR, 0.19; 95% CI, 0.04-0.85) as disadvantages to the IUD were significantly associated with no interest in receiving a PPIUD. Interest did not differ by male involvement. CONCLUSION: Recommendations to increase PPIUD uptake include educating pregnant women and couples about the method during ANC and addressing client myths and misconceptions about the IUD. This strategy allows pregnant women and couples to make informed decisions about their future contraception use, reduce unmet need for family planning, and reduce unintended pregnancy.

Evaluation of a multi-level intervention to improve postpartum intrauterine device services in Rwanda.

Background. The copper intrauterine device is one of the most safe, effective, and cost-effective methods for preventing unintended pregnancy. It can be used postpartum irrespective of breastfeeding to improve birth spacing and reduce unintended pregnancy and maternal-child mortality. However, this method remains highly underutilized. Methods. We developed a multi-level intervention to increase uptake of the postpartum intrauterine device (PPIUD, defined as insertion up to six weeks post-delivery) in Kigali, Rwanda. High-volume hospitals and health centers were selected for implementation of PPIUD counseling and service delivery. Formative work informed development of a PPIUD counseling flipchart to be delivered during antenatal care, labor and delivery, infant vaccination visits, or in the community. Two-day didactic counseling, insertion/removal, and follow-up trainings were provided to labor and delivery and family planning nurses followed by a mentored practicum certification process. Counseling data were collected in government clinic logbooks. Insertions and follow-up data were collected in logbooks created for the implementation. Data were collected by trained government clinic staff and abstracted/managed by study staff. Stakeholders were involved from intervention development through dissemination of results. Results. Two hospitals (and their two associated health centers) and two additional health centers were selected. In 6-months prior to our intervention, 7.7 PPIUDs/month were inserted on average at the selected facilities. From August 2017-July 2018, we trained 83 counselors and 39 providers to provide PPIUD services. N=9,020 women received one-on-one PPIUD counseling after expressing interest in family planning who later delivered at a selected health facility. Of those, n=2,575 had PPIUDs inserted (average of 214.6 insertions/month), a 29% uptake. Most PPIUDs (62%) were inserted within 10 minutes of delivery of the placenta. Conclusions. This successful, comprehensive intervention has the potential to make a significant impact on PPIUD uptake in Rwanda. The intervention is scalable and adaptable to other sub-Saharan African countries.

Influences in fertility decisions among HIV-infected individuals in Lilongwe, Malawi: a qualitative study.

BACKGROUND: The motivation to have a child may be complex with numerous influencing factors, particularly among individuals living with HIV. This study sought to understand factors influencing fertility decision-making for HIV-infected men and women in Lilongwe, Malawi. METHODS: Thirteen focus groups were conducted among HIV-infected individuals enrolled in antiretroviral treatment services. RESULTS: Participants identified a hierarchy of influences in fertility decisions including the importance of childbearing, patriarchal influence, family influences and concern regarding HIV transmission. CONCLUSIONS: Addressing fertility conversations beyond the confines of a relationship may be important, as family plays a significant role in fertility choices. Childbearing remains a fundamental desire among many individuals with HIV; however, concerns regarding transmission risk need to be addressed with efforts made to overcome misconception and assist individuals in balancing what may be competing influences.