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.

Favorable Impact of Community Adherence Support Groups on Retention in Care and Viral Suppression Rates Among Persons with HIV Receiving Antiretroviral Therapy in Mozambique

The community adherence support group (CASG) was one of the first differentiated service delivery (DSD) models introduced in Mozambique. This study assessed the impact of this model on retention in care, loss to follow-up (LTFU), and viral suppression among antiretroviral therapy (ART)-treated adults in Mozambique. A retrospective cohort study included CASG-eligible adults enrolled between April 2012 and October 2017 at 123 health facilities in Zambézia Province. Propensity score matching (1:1 ratio) was used to allocate CASG members and those who never enrolled in a CASG. Logistic regressions were performed to estimate the impact of CASG membership on 6- and 12-month retention and viral load (VL) suppression. Cox proportional regression was used to model differences in LTFU. Data from 26,858 patients were included. The median age at CASG eligibility was 32 years and 75% were female, with 84% residing in rural areas. A total of 93% and 90% of CASG members were retained in care at 6 and 12 months, respectively, while 77% and 66% non-CASG members were retained during the same periods. The odds of being retained in care at 6 and 12 months were significantly higher among patients receiving ART through CASG support (adjusted odds ratio [aOR] = 4.19 [95% confidence interval; CI: 3.79-4.63], p < .001, and aOR = 4.43 [95% CI: 4.01-4.90], p < .001, respectively). Among 7,674 patients with available VL measurements, the odds of being virally suppressed were higher among CASG members (aOR = 1.14 [95% CI: 1.02-1.28], p < .001). Non-CASG members had a significantly higher likelihood of being LTFU (adjusted hazard ratio = 3.45 [95% CI: 3.20-3.73], p < .001). While Mozambique rapidly scales up multi-month drug dispensation as the preferred DSD model, this study emphasizes the continued importance of CASG as an efficacious DSD alternative, especially among patients residing in rural areas, where CASG acceptability is higher.

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.

Health care services for survivors of gender-based violence: a community and clinic-based intervention in Zambézia province, Mozambique

Moçambique introduziu directrizes para serviços integrados de violência baseada no género (VBG) em 2012. Em 2017, formámos prestadores de serviços em serviços empáticos e de apoio aos sobreviventes da VBG e introduzimos serviços domiciliários para sobreviventes que não têm acompanhamento. As proporções de taxas de visitas clínicas foram comparadas antes e depois do início da intervenção, utilizando testes de significância exata. Foram revistos dados de 1.806 sobreviventes da VBG, com um total de 2.005 eventos. A idade mediana foi de 23 anos (IQR 17-30) e 89% eram mulheres. Entre aqueles que relataram violência, 69% relataram violência física, 18% relataram violência sexual (VS) e 12% relataram violência psicológica. As taxas de comportamento de procura de cuidados foram maiores no período de intervenção (razão de taxas 1,31 [IC95%: 1,18-1,46]); p < 0,01. Entre aqueles elegíveis para profilaxia pós-exposição (PEP), 94% iniciaram a PEP. A adesão ao novo teste de HIV melhorou em pontos percentuais em 34% (14% para 48%), 34% (8% para 42%) e 26% (5% para 31%) em 1, 3 e 6 meses, respectivamente . A intervenção levou a um aumento na taxa de sobreviventes de VBG que procuram serviços de saúde e melhorou as taxas de cuidados de acompanhamento entre os sobreviventes de VS que iniciaram a PEP. O reforço do aconselhamento sobre adesão à PEP continua a ser crucial para melhorar os serviços de VBG.

CD4 Trends with evolving treatment initiation policies among children living with HIV in zambézia province, mozambique, 2012-2018

Background: Historically, antiretroviral therapy (ART) initiation was based on CD4 criteria, but this has been replaced with "Test and Start" wherein all people living with HIV are offered ART. We describe the baseline immunologic status among children relative to evolving ART policies in Mozambique. Methods: This retrospective evaluation was performed using routinely collected data. Children living with HIV (CL aged 5-14 years) with CD4 data in the period of 2012-2018 were included. ART initiation "policy periods" corresponded to implementation of evolving guidelines: in period 1 (2012-2016), ART was recommended for CD4 <350 cells/mm3; during period 2 (2016-2017), the CD4 threshold increased to <500 cells/mm3; Test and Start was implemented in period 3 (2017-2018). We described temporal trends in the proportion of children with severe immunodeficiency (CD4 <200 cells/mm3) at enrollment and at ART initiation. Multivariable regression models were used to estimate associations with severe immunodeficiency. Results: The cohort included 1815 children with CD4 data at enrollment and 1922 at ART initiation. The proportion of children with severe immunodeficiency decreased over time: 20% at enrollment into care in period 1 vs. 16% in period 3 (P = 0.113) and 21% at ART initiation in period 1 vs. 15% in period 3 (P = 0.004). Children initiating ART in period 3 had lower odds of severe immunodeficiency at ART initiation compared with those in period 1 [adjusted odds ratio (aOR) = 0.67; 95% CI: 0.51 to 0.88]. Older age was associated with severe immunodeficiency at enrollment (aOR = 1.13; 95% CI: 1.06 to 1.20) and at ART initiation (aOR = 1.14; 95% CI: 1.08 to 1.21). Conclusions: The proportion of children with severe immunodeficiency at ART initiation decreased alongside more inclusive ART initiation guidelines. Earlier treatment of children living with HIV is imperative.

Young at risk-people in Maputo City, Mozambique, present a high willingness to participate in HIV trials: Results from an HIV vaccine preparedness cohort study

Introduction: Vaccine efficacy testing requires engagement of willing volunteers with high disease incidence. We evaluated factors associated with willingness to participate in potential future HIV vaccine trials in Maputo, Mozambique. Methods: Adults aged 18-35 years without HIV and who reported at least two sexual partners in the 3 months prior to screening were enrolled into a 24-month observational study. They were asked at screening and exit if they would be willing to participate in a theoretical HIV vaccine study. Bivariate and multivariate logistic regression analyses were done between willingness to participate, demographic, sexual behavior, and motivational factors for screening visit data. Logistic regression with generalized estimating equations (GEE) was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors potentially associated with willingness to participate for data from both visits. Results: A total of 577 participants without HIV were eligible, including 275 (48%) women. The mean age was 22.2 (SD ± 3.9) years. At screening 529 (92%) expressed willingness to participate and the proportion remained stable at 378 (88%) of the 430 participants retained through the exit visit (p = 0.209). Helping the country (n = 556) and fear of needles (n = 26) were the top motive and barrier for willingness to participate, respectively. Results from the GEE binary logistic regression (screening visit and exit visit) showed that wanting to learn how to avoid risk behaviors (aOR 3.33, 95% CI: 1.61-6.86) and feeling protected against HIV infection (aOR 2.24, 95% CI: 1.07-4.7) were associated with willingness to participate in HIV vaccine studies. Conclusion: The majority of our study population in Mozambique expressed willingness to participate in a theoretical HIV vaccine trial. Participation in a HIV vaccine trial was seen as a way to contribute to the fight against HIV but was associated with some unrealistic expectations such as protection against HIV. This reinforces the need for continuous mobilization and awareness of potential participants to HIV vaccine trial.

HIV infection in Eastern and Southern Africa: Highest burden, largest challenges, greatest potential.

BACKGROUND: The burden of HIV is especially concerning for Eastern and Southern Africa (ESA), as despite expansion of test-and-treat programmes, this region continues to experience significant challenges resulting from high rates of morbidity, mortality and new infections. Hard-won lessons from programmes on the ground in ESA should be shared. OBJECTIVES: This report summarises relevant evidence and regional experts' recommendations regarding challenges specific to ESA. METHOD: This commentary includes an in-depth review of relevant literature, progress against global goals and consensus opinion from experts. RESULTS: Recommendations include priorities for essential research (surveillance data collection, key and vulnerable population education and testing, in-country testing trials and evidence-based support services to improve retention in care) as well as research that can accelerate progress towards the prevention of new infections and achieving ambitious global goals in ESA. CONCLUSION: The elimination of HIV in ESA will require continued investment, commitment to evidence-based programmes and persistence. Local research is critical to ensuring that responses in ESA are targeted, efficient and evaluated.

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.

Interpersonal reactivity index adaptation among expectant seroconcordant couples with HIV in Zambézia Province, Mozambique

The ability to understand another's emotions and act appropriately, empathy, is an important mediator of relationship function and health intervention fidelity. We adapted the Interpersonal Reactivity Index (IRI) ­ an empathy scale ­ among seroconcordant expectant couples with HIV in the Homens para Saúde Mais (HoPS+) trial ­ a cluster randomized controlled trial assessing couple-based versus individual treatment on viral suppression ­ in Zambézia Province, Mozambique. Methods: Using baseline data from 1332 HoPS+ trial participants (666 couples), an exploratory factor analysis assessed culturally relevant questions from the IRI. Because empathy is interdependent among couples, we validated the results of the exploratory factor analysis using a dyadic confirmatory factor analysis (CFA) with dyadic measurement invariance testing. Finally, we assessed the relationship between scores on our final scale and basic demographic characteristics (sex, age, education, and depression) using t-tests. Results: We found two subscales: 1) a seven-item cognitive empathy subscale (Cronbach's alpha 0.78) and 2) a six-item affective empathy subscale (Cronbach's alpha 0.73). The dyadic CFA found acceptable model fit and metric invariance across partners (Comparative Fit Index (CFI) = 0.914, Tucker Lewis Index = 0.904, Root Mean Squared Error of Approximation = 0.056, ΔCFI = 0.011). We observed higher cognitive (p: 0.012) and affective (p: 0.049) empathy among males and higher cognitive (p: 0.031) and affective (p: 0.030) empathy among younger participants. More educated participants had higher affective empathy (p: 0.017) and depressed participants had higher cognitive empathy (p: < 0.001). This two-subscale, 13-item version of the IRI measures cognitive and affective empathy in HoPS+ trial participants and adults while accounting for the interdependent nature of empathy within partner dyads. Conclusions: This scale will allow us to assess the interplay between empathy and other psychometric constructs (stigma, social support, etc.) in the HoPS+ trial and how each relates to retention in HIV, adherence to treatment, and prevention of maternal to child HIV transmission. Furthermore, this scale can be adapted for other sub-Saharan African populations, which will allow researchers to better assess HIV-related intervention efficacy. Trial registration: This study is within the context of the HoPS+ trial, registered at ClinicalTrials.gov as number

Immunodeficiency at antiretroviral therapy start: five-Year adult data (2012-2017) based on evolving national policies in rural mozambique

Before the 2015 implementation of "Test and Start," the initiation of combination antiretroviral therapy (ART) was guided by specific CD4 cell count thresholds. As scale-up efforts progress, the prevalence of advanced HIV disease at ART initiation is expected to decline. We analyzed the temporal trends in the median CD4 cell counts among adults initiating ART and described factors associated with initiating ART with severe immunodeficiency in Zambézia Province, Mozambique. We included all HIV-positive, treatment-naive adults (age ≥ 15 years) who initiated ART at a Friends in Global Health (FGH)-supported health facility between September 2012 and September 2017. Quantile regression and multivariable logistic regression models were applied to ascertain the median change in CD4 cell count and odds of initiating ART with severe immunodeficiency, respectively. A total of 68,332 patients were included in the analyses. The median change in CD4 cell count under "Test and Start" was higher at +68 cells/mm3 (95% CI: 57.5-78.4) compared with older policies. Younger age and female sex (particularly those pregnant/lactating) were associated with higher median CD4 cell counts at ART initiation. Male sex, advanced age, WHO Stage 4 disease, and referrals to the health facility through inpatient provider-initiated testing and counseling (PITC) were associated with higher odds of initiating ART with severe immunodeficiency. Although there were reassuring trends in increasing median CD4 cell counts with ART initiation, ongoing efforts are needed that target universal HIV testing to ensure the early initiation of ART in men and older patients.

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.

Factors influencing mother-to-child transmission of HIV during pregnancy and breastfeeding in Mozambique

The earliest reports of a new disease were seen in the late seventies-early eighties, after observing rare opportunistic diseases such as Kaposi Sarcoma or Pneumocystis carinii pneumonia, usually occurring in immunodeprimed people, in a cluster of intravenous drug users and gay men in the United States. The syndrome was called AIDS, Acquired Immunodeficiency Syndrome. In Africa, AIDS was first seen in 1982 in Uganda, and shortly after in other countries of the continent. In 1983, scientists from independent research groups in the United States (Gallo et al.) and in France (Barre- Sinoussi et al.) discovered the virus that causes AIDS [1,2]. The virus was at first named HTLV-III/LAV (human T-cell lymphotropic virus-type III/lymphadenopathy-associated virus) and later renamed to HIV (human immunodeficiency virus). The HIV virus belongs to the Retroviridae family. The classification is done by phylogenetic analysis and nucleotidic sequencing of the viruses.

High HIV incidence in the postpartum period sustains vertical transmission in settings with generalized epidemics: a cohort study in Southern Mozambique

Introduction: Acute infection with HIV in the postpartum period results in a high risk of vertical transmission through breastfeeding. A study was done to determine the HIV incidence rate and associated risk factors among postpartum women in Southern Mozambique, where HIV prevalence among pregnant women is 21%. Methods: A prospective cohort study was conducted in six rural health facilities in Gaza and Maputo provinces from March 2008 to July 2011. A total of 1221 women who were HIV-negative on testing at delivery or within two months postpartum were recruited and followed until 18 months postpartum. HIV testing, collection of dried blood spot samples and administration of a structured questionnaire to women were performed every three months. Infant testing by DNA-PCR was done as soon as possible after identification of a new infection in women. HIV incidence was estimated, and potential risk factors at baseline were compared using Poisson regression. Results: Data from 957 women were analyzed with follow-up after the enrolment visit, with a median follow-up of 18.2 months. The HIV incidence in postpartum women is estimated at 3.20/100 women-years (95% CI: 2.30-4.46), with the highest rate among 18- to 19-year-olds (4.92 per 100 women-years; 95% CI: 2.65-9.15). Of the new infections, 14 (34%) were identified during the first six months postpartum, 11 (27%) between 6 and 12 months and 16 (39%) between 12 and 18 months postpartum. Risk factors for incident HIV infection include young age, low number of children, higher education level of the woman's partner and having had sex with someone other than one's partner. The vertical transmission was 21% (95% CI: 5-36) among newly infected women. Conclusions: Incidence of HIV is high among breastfeeding women in Southern Mozambique, contributing to increasing numbers of HIV-infected infants. Comprehensive primary prevention strategies targeting women of reproductive age, particularly pregnant and postpartum women and their partners, will be crucial for the elimination of paediatric AIDS in Africa.