Partner-Based HIV Treatment for Seroconcordant Couples Attending Antenatal and Postnatal Care in Rural Mozambique: A Cluster Randomized Controlled Trial.

INTRODUCTION: There is evidence that a supportive male partner facilitates maternal HIV testing during pregnancy, increases maternal antiretroviral therapy initiation and adherence, and increases HIV-free infant survival. Most male partner engagement clinical strategies have focused on increasing uptake of couple-based HIV testing and counseling. We delivered a couple-based care and treatment intervention to improve antiretroviral therapy adherence in expectant couples living with HIV. METHODS: We implemented a cluster randomized controlled trial for seroconcordant couples living with HIV, comparing retention (using a patient's medication possession ratio) in HIV care for a couple-based care and treatment intervention vs. standard of care services in rural Mozambique. The intervention included couple-based treatment, couple-based education and skills building, and couple-peer educator support. RESULTS: We recruited 1080 couples to participate in the study. Using a linear mixed effect model with a random effect for clinic, the intervention had no impact on the medication possession ratio among women at 12 months. However, the intervention increased men's medication ratio by 8.77%. Our unadjusted logistic regression model found the odds of an infant seroconverting in the intervention group was 30% less than in the control group, but the results were not statistically significant. DISCUSSION: Our study found no difference in maternal outcomes by study arm, but our intervention resulted in an improved medication possession ratio among male partners. We provide a community/clinic-based treatment framework that can improve outcomes among male partners. Further work needs to be done to improve social support for pregnant women and to facilitate prevention of vertical transmission to infants among couples living with HIV.

Healthcare Providers' Perspectives on a Novel Couple-Based HIV Treatment Intervention: A Qualitative Assessment of the Facilitators, Barriers, and Proposed Improvements to Implementation in Zambézia Province, Mozambique.

Mozambique has one of the world's highest HIV/AIDS burdens. Despite significant investment in HIV care and treatment, pregnant and lactating women's retention in care remains suboptimal. One reason for poor maternal retention is lack of male partner support. We tested an interventional couple-based HIV care and treatment, including joint clinical appointments and couple-based educational and support sessions provided by a health counselor and peer educators, respectively. Healthcare providers delivering care for seroconcordant individuals were interviewed regarding their perspectives on facilitators and barriers to the couple-based intervention implementation. Analysis of interview responses was done using MAXQDA. Results pertaining to providers' perspectives on implementation and intervention characteristics were organized, interpreted, and contextualized using the Consolidated Framework for Implementation Research (CFIR 2.0), while providers' suggestions for improvements were coded and organized apart from CFIR. Providers felt the intervention was largely compatible with the local culture, and offered a significant advantage over standard individual-based care by facilitating patient follow-up and reducing wait times by prioritizing couples for services. They also believed it facilitated HIV treatment access through the provision of couple-based counseling that encouraged supportive behaviors towards retention. However, providers reported insufficient privacy to deliver couple-based care at some health facilities and concerns that women in difficult relationships may struggle to meaningfully participate. They suggested providing sessions in alternate clinic settings and offering a limited number of women-only visits. The facilitators and barriers described here contribute to informing the design and implementation of future couple-based interventions to improve HIV care for seroconcordant expectant couples.

Healthcare providers' perspectives on a novel couple-based HIV treatment intervention: A qualitative assessment of the facilitators, barriers, and proposed improvements to implementation in zambézia province, mozambique

Mozambique has one of the world's highest HIV/AIDS burdens. Despite significant investment in HIV care and treatment, pregnant and lactating women's retention in care remains suboptimal. One reason for poor maternal retention is lack of male partner support. We tested an interventional couple-based HIV care and treatment, including joint clinical appointments and couple-based educational and support sessions provided by a health counselor and peer educators, respectively. Healthcare providers delivering care for seroconcordant individuals were interviewed regarding their perspectives on facilitators and barriers to the couple-based intervention implementation. Analysis of interview responses was done using MAXQDA. Results pertaining to providers' perspectives on implementation and intervention characteristics were organized, interpreted, and contextualized using the Consolidated Framework for Implementation Research (CFIR 2.0), while providers' suggestions for improvements were coded and organized apart from CFIR. Providers felt the intervention was largely compatible with the local culture, and offered a significant advantage over standard individual-based care by facilitating patient follow-up and reducing wait times by prioritizing couples for services. They also believed it facilitated HIV treatment access through the provision of couple-based counseling that encouraged supportive behaviors towards retention. However, providers reported insufficient privacy to deliver couple-based care at some health facilities and concerns that women in difficult relationships may struggle to meaningfully participate. They suggested providing sessions in alternate clinic settings and offering a limited number of women-only visits. The facilitators and barriers described here contribute to informing the design and implementation of future couple-based interventions to improve HIV care for seroconcordant expectant couples.

Attitudes and perceptions towards postpartum contraceptive use among seroconcordant partners with HIV in rural Mozambique: a qualitative study.

BACKGROUND: Postpartum contraceptive uptake reduces short interpregnancy intervals, unintended pregnancies, and their negative sequalae: poor maternal and fetal outcomes. Healthy timing and spacing of pregnancy in people living with HIV (PLHIV) also allows time to achieve viral suppression to reduce parent-to-child HIV transmission. There is scant understanding about how couples-based interventions impact postpartum contraceptive uptake among PLHIV in sub-Saharan Africa. METHODS: We interviewed 38 recently pregnant people and 26 of their partners enrolled in the intervention arm of the Homens para Saúde Mais (HoPS+) [Men for Health Plus] trial to assess their perceptions of, attitudes towards, and experiences with contraceptive use. Individuals in the HoPS+ intervention arm received joint-as opposed to individual-HIV-related services during pregnancy and postpartum periods, six counseling and skills sessions, and nine sessions with a peer support couple. Our thematic analysis of the 64 in-depth interviews generated 14 deductive codes and 3 inductive codes across themes within the Information, Motivation, and Behavior Model of health behavior change. RESULTS: Participants reported accurate and inaccurate information about birth spacing and contraceptive methods. They described personal (health, economic, and religious) and social (gender norms, desired number of children) motivations for deciding whether to use contraceptives-with slightly different motivations among pregnant and non-pregnant partners. Finally, they explained the skills needed to overcome barriers to contraceptive use including how engagement in HoPS+ improved their shared decision-making skills and respect amongst partners-which facilitated postpartum contraceptive uptake. There were also several cases where non-pregnant partners unilaterally made family planning decisions despite disagreement from their partner. CONCLUSIONS: These findings suggest that couples-based interventions during pregnancy and post-partum periods aimed at increasing postpartum contraceptive uptake must center pregnant partners' desires. Specifically, pregnant partners should be allowed to titrate the level of non-pregnant partner involvement in intervention activities to avoid potentially emboldening harmful gender-based intercouple decision-making dynamics.

Attitudes and perceptions towards postpartum contraceptive use among seroconcordant partners with HIV in rural Mozambique: a qualitative study

Background Postpartum contraceptive uptake reduces short interpregnancy intervals, unintended pregnancies, and their negative sequalae: poor maternal and fetal outcomes. Healthy timing and spacing of pregnancy in people living with HIV (PLHIV) also allows time to achieve viral suppression to reduce parent-to-child HIV transmission. There is scant understanding about how couples-based interventions impact postpartum contraceptive uptake among PLHIV in sub-Saharan Africa. Methods We interviewed 38 recently pregnant people and 26 of their partners enrolled in the intervention arm of the Homens para Saúde Mais (HoPS+) [Men for Health Plus] trial to assess their perceptions of, attitudes towards, and experiences with contraceptive use. Individuals in the HoPS+intervention arm received joint­as opposed to individual­HIV-related services during pregnancy and postpartum periods, six counseling and skills sessions, and nine sessions with a peer support couple. Our thematic analysis of the 64 in-depth interviews generated 14 deductive codes and 3 inductive codes across themes within the Information, Motivation, and Behavior Model of health behavior change. Results Participants reported accurate and inaccurate information about birth spacing and contraceptive methods. They described personal (health, economic, and religious) and social (gender norms, desired number of children) motivations for deciding whether to use contraceptives­with slightly diferent motivations among pregnant and non-pregnant partners. Finally, they explained the skills needed to overcome barriers to contraceptive use including how engagement in HoPS+improved their shared decision-making skills and respect amongst partners­which facilitated postpartum contraceptive uptake. There were also several cases where non-pregnant partners unilaterally made family planning decisions despite disagreement from their partner. Conclusions These fndings suggest that couples-based interventions during pregnancy and post-partum periods aimed at increasing postpartum contraceptive uptake must center pregnant partners' desires. Specifcally, pregnant partners should be allowed to titrate the level of non-pregnant partner involvement in intervention activities to avoid potentially emboldening harmful gender-based intercouple decision-making dynamics.

Pre-exposure prophylaxis use among HIV serodiscordant couples: a qualitative study in Mozambique.

BACKGROUND: Pre-exposure prophylaxis (PrEP) has the potential to reduce HIV transmission and stem the HIV epidemic. Unfortunately, PrEP uptake in rural sub-Saharan Africa has been slow and medication adherence has been suboptimal. OBJECTIVE: To explore the perspectives, attitudes, and experiences of HIV serodiscordant partners taking PrEP and develop a messaging campaign to improve PrEP uptake in rural Mozambique to reduce HIV transmission among serodiscordant partners. METHODS: In this qualitative study, we interviewed 20 people in serodiscordant relationships using PrEP at a rural health center in Zambézia province, Mozambique and employed inductive and deductive coding to elicit their perspectives, attitudes, and experiences related to learning their partner's HIV status, barriers to PrEP uptake, obstacles to PrEP adherence, and decisions to disclose their PrEP use with family and friends using thematic analysis. RESULTS: Our analysis generated nine themes across various levels of the socioecological model. Participants reported a strong desire to stay in the discordant relationship and highlighted the importance of working together to ensure PrEP and antiretroviral therapy adherence, with the majority skeptical that adherence could be achieved without both partners' support (individual and interpersonal). Although most participants were reticent about sharing their serodiscordant status with family and friends (individual and interpersonal), those who did found their family and friends supportive (interpersonal). Participants suggested increasing community health agent availability to help people navigate HIV prevention and treatment (organizational). We then created three oral stories, using themes from the interviews, with examples from various levels of the socioecological model that will be used to generate support for PrEP use among community members. CONCLUSIONS: Our findings informed oral template stories that will be used to emphasize how couples can work together to improve PrEP uptake and reduce incident HIV infections in serodiscordant couples elsewhere in rural Mozambique.

Effect of a storytelling intervention on the retention of serodiscordant couples in ART/PrEP services at antenatal clinic in Namacurra province in Zambézia, Mozambique.

BACKGROUND: Sub-Saharan Africa reported 550,000 new HIV infections among women in 2018. Pregnancy and the postpartum period are associated with an increased risk of HIV acquisition (adjusted risk ratio [RR]: 2.8 during pregnancy and 4.0 in postpartum period vs. non-pregnant or postpartum women, respectively). Acquisition of HIV during pregnancy and breastfeeding increases risk of mother to child transmission. We propose to test the impact of a peer-delivered oral storytelling intervention to increase retention in, and adherence to, pre-exposure prophylaxis (PrEP)/combination antiretroviral treatment (ART) among expectant couples. DESIGN: We propose a randomized controlled trial (RCT) (35 intervention and 35 control couples) at a health facility where 11% of expectant couples were in serodiscordant relationships in 2018. Couples randomized to the storytelling arm will be visited by a two community volunteers and who successfully adhered to PrEP/ART during a recent pregnancy. This expert couple will orate to participating couples three stories (at 1, 3 and 5 weeks after study enrollment) designed to empower, educate, and establish "ideal" interpersonal communication strategies within couples/families, and support adherence practices among participants. The primary outcome among HIV-uninfected women will be adherence to PrEP at 3 months. CONCLUSIONS: PrEP among at-risk pregnant women must be implemented so that high levels of adherence and retention are achievable for them and their partners. We will test our storytelling intervention to identify an optimal strategy for PrEP education and family engagement in a region with high HIV prevalence. Our results will have an impact by effectively engaging serodiscordant couples in prevention/treatment during pregnancy and beyond.

Effect of storytelling intervention of serodiscordant couples in ART/PrEP services at antenatal clinic in namacura province in zambézia, Moçambique

Background: Sub-Saharan Africa reported 550,000 new HIV infections among women in 2018. Pregnancy and the postpartum period are associated with an increased risk of HIV acquisition (adjusted risk ratio [RR]: 2.8 during pregnancy and 4.0 in postpartum period vs. non-pregnant or postpartum women, respectively). Acquisition of HIV during pregnancy and breastfeeding increases risk of mother to child transmission. We propose to test the impact of a peer-delivered oral storytelling intervention to increase retention in, and adherence to, pre-exposure prophylaxis (PrEP)/combination antiretroviral treatment (ART) among expectant couples. Design: We propose a randomized controlled trial (RCT) (35 intervention and 35 control couples) at a health facility where 11% of expectant couples were in serodiscordant relationships in 2018. Couples randomized to the storytelling arm will be visited by a two community volunteers and who successfully adhered to PrEP/ART during a recent pregnancy. This expert couple will orate to participating couples three stories (at 1, 3 and 5 weeks after study enrollment) designed to empower, educate, and establish "ideal" interpersonal communication strategies within couples/families, and support adherence practices among participants. The primary outcome among HIV-uninfected women will be adherence to PrEP at 3 months. Conclusions: PrEP among at-risk pregnant women must be implemented so that high levels of adherence and retention are achievable for them and their partners. We will test our storytelling intervention to identify an optimal strategy for PrEP education and family engagement in a region with high HIV prevalence. Our results will have an impact by effectively engaging serodiscordant couples in prevention/treatment during pregnancy and beyond.

Pre-exposure prophylaxis use among HIV serodiscordant couples: a qualitative study in Mozambique

Background: Pre-exposure prophylaxis (PrEP) has the potential to reduce HIV transmission and stem the HIV epidemic. Unfortunately, PrEP uptake in rural sub-Saharan Africa has been slow and medication adherence has been suboptimal. Objective: To explore the perspectives, attitudes, and experiences of HIV serodiscordant partners taking PrEP and develop a messaging campaign to improve PrEP uptake in rural Mozambique to reduce HIV transmission among serodiscordant partners. Methods: In this qualitative study, we interviewed 20 people in serodiscordant relationships using PrEP at a rural health center in Zambézia province, Mozambique and employed inductive and deductive coding to elicit their perspectives, attitudes, and experiences related to learning their partner's HIV status, barriers to PrEP uptake, obstacles to PrEP adherence, and decisions to disclose their PrEP use with family and friends using thematic analysis. Results: Our analysis generated nine themes across various levels of the socioecological model. Participants reported a strong desire to stay in the discordant relationship and highlighted the importance of working together to ensure PrEP and antiretroviral therapy adherence, with the majority skeptical that adherence could be achieved without both partners' support (individual and interpersonal). Although most participants were reticent about sharing their serodiscordant status with family and friends (individual and interpersonal), those who did found their family and friends supportive (interpersonal). Participants suggested increasing community health agent availability to help people navigate HIV prevention and treatment (organizational). We then created three oral stories, using themes from the interviews, with examples from various levels of the socioecological model that will be used to generate support for PrEP use among community members. Conclusions: Our findings informed oral template stories that will be used to emphasize how couples can work together to improve PrEP uptake and reduce incident HIV infections in serodiscordant couples elsewhere in rural Mozambique.

Partners-based HIV treatment for seroconcordant couples attending antenatal and postnatal care in rural Mozambique: A cluster randomized trial protocol

Background: In resource-limited rural settings, scale-up of services to eliminate mother-to-child transmission of HIV has not been as effective as in better resourced urban settings. In sub-Saharan Africa, women often require male partner approval to access and remain engaged in HIV care. Our study will evaluate a promising male engagement intervention ("Homens para Saúde Mais" (HoPS+) [Men for Health Plus]) targeting the elimination of mother-to-child transmission in rural Mozambique. Design: We will use a cluster randomized clinical trial design to engage 24 health facilities (12 intervention and 12 standard of care), with 45 HIV-infected seroconcordant couples per clinic. The planned intervention will engage male partners to address social-structural and cultural factors influencing eMTCT based on new couple-centered integrated HIV services. Conclusions: The HoPS+ study will evaluate the effectiveness of engaging male partners in antenatal care to improve outcomes among HIV-infected pregnant women, their HIV-infected male partners, and their newborn children. Our objectives are to: (1) Implement and evaluate the impact of male-engaged, couple-centered services on partners' retention in care, adherence to antiretroviral therapy, early infant diagnosis uptake, and mother-to-child transmission throughout pregnancy and breastfeeding; (2) Investigate the impact of HoPS+ intervention on hypothesized mechanisms of change; and (3) Use validated simulation models to evaluate the cost-effectiveness of the HoPS+ intervention with the use of routine clinical data from our trial. We expect the intervention to lead to strategies that can improve outcomes related to partners' retention in care, uptake of services for HIV-exposed infants, and reduced MTCT.

Partners-based HIV treatment for seroconcordant couples attending antenatal and postnatal care in rural Mozambique: A cluster randomized trial protocol.

BACKGROUND: In resource-limited rural settings, scale-up of services to eliminate mother-to-child transmission of HIV has not been as effective as in better resourced urban settings. In sub-Saharan Africa, women often require male partner approval to access and remain engaged in HIV care. Our study will evaluate a promising male engagement intervention ("Homens para Saúde Mais" (HoPS+) [Men for Health Plus]) targeting the elimination of mother-to-child transmission in rural Mozambique. DESIGN: We will use a cluster randomized clinical trial design to engage 24 health facilities (12 intervention and 12 standard of care), with 45 HIV-infected seroconcordant couples per clinic. The planned intervention will engage male partners to address social-structural and cultural factors influencing eMTCT based on new couple-centered integrated HIV services. CONCLUSIONS: The HoPS+ study will evaluate the effectiveness of engaging male partners in antenatal care to improve outcomes among HIV-infected pregnant women, their HIV-infected male partners, and their newborn children. Our objectives are to: (1) Implement and evaluate the impact of male-engaged, couple-centered services on partners' retention in care, adherence to antiretroviral therapy, early infant diagnosis uptake, and mother-to-child transmission throughout pregnancy and breastfeeding; (2) Investigate the impact of HoPS+ intervention on hypothesized mechanisms of change; and (3) Use validated simulation models to evaluate the cost-effectiveness of the HoPS+ intervention with the use of routine clinical data from our trial. We expect the intervention to lead to strategies that can improve outcomes related to partners' retention in care, uptake of services for HIV-exposed infants, and reduced MTCT.

Partners-based HIV treatment for seroconcordant couples attending antenatal and postnatal care in rural Mozambique: A cluster randomized trial protocol

Background: In resource-limited rural settings, scale-up of services to eliminate mother-to-child transmission of HIV has not been as effective as in better resourced urban settings. In sub-Saharan Africa, women often require male partner approval to access and remain engaged in HIV care. Our study will evaluate a promising male engagement intervention ("Homens para Saúde Mais" (HoPS+) [Men for Health Plus]) targeting the elimination of mother-to-child transmission in rural Mozambique. Design: We will use a cluster randomized clinical trial design to engage 24 health facilities (12 intervention and 12 standard of care), with 45 HIV-infected seroconcordant couples per clinic. The planned intervention will engage male partners to address social-structural and cultural factors influencing eMTCT based on new couple-centered integrated HIV services. Conclusions: The HoPS+ study will evaluate the effectiveness of engaging male partners in antenatal care to improve outcomes among HIV-infected pregnant women, their HIV-infected male partners, and their newborn children. Our objectives are to: (1) Implement and evaluate the impact of male-engaged, couple-centered services on partners' retention in care, adherence to antiretroviral therapy, early infant diagnosis uptake, and mother-to-child transmission throughout pregnancy and breastfeeding; (2) Investigate the impact of HoPS+ intervention on hypothesized mechanisms of change; and (3) Use validated simulation models to evaluate the cost-effectiveness of the HoPS+ intervention with the use of routine clinical data from our trial. We expect the intervention to lead to strategies that can improve outcomes related to partners' retention in care, uptake of services for HIV-exposed infants, and reduced MTCT.