A peer-facilitated psychological group intervention for perinatal women living with HIV and depression in Tanzania-Healthy Options: A cluster-randomized controlled trial.

BACKGROUND: Perinatal women living with HIV (PWLH) have a greater risk of depression compared to other women; however, there are limited specialized mental health services available to them. We aimed to determine whether a stepped-care intervention facilitated by trained lay providers can improve mental health outcomes postpartum for PWLH. METHODS AND FINDINGS: Healthy Options is a cluster-randomized controlled study conducted in 16 government-managed antenatal care clinics that provided HIV care for pregnant women in urban Tanzania. Recruitment occurred from May 2015 through April 2016, with the final round of data collection completed in October 2017. Participants included a consecutive sample of pregnant women under 30 weeks of gestation, living with HIV and depression, and attending the study clinics. Control sites received enhanced usual care for depression (EUDC). Intervention sites received EUDC plus the Healthy Options intervention, which includes prenatal group sessions of problem-solving therapy (PST) plus cognitive behavioral therapy (CBT) sessions for individuals showing depressive symptoms at 6 weeks postdelivery. We assessed depressive symptoms comparable to major depressive disorder (MDD) using the Patient Health Questionnaire-9 (PHQ-9) with a locally validated cutoff at 9 months and 6 weeks postpartum. The primary time point is 9 months postpartum. We examined differences in outcomes using an intent-to-treat analysis with a complete case approach, meaning those with data at the relevant time point were included in the analysis. We used generalized estimating equations accounting for clustering. Of 818 women screened using the PHQ-9, 742 were determined eligible and enrolled (395 intervention; 347 control); 649 women (87.5%) participated in the first follow-up and 641 women (86.4%) in the second. A majority (270, 74.6%) of women in the intervention arm attended 5 or more PST sessions. Women enrolled in Healthy Options demonstrated a 67% (RR 0.33; 95% CI: 0.22, 0.51; p-value: <0.001; corresponding to a 25.7% difference in absolute risk) lower likelihood of depressive symptoms than women in control clusters at 6 weeks postpartum. At 9 months postpartum, women enrolled in Healthy Options demonstrated a nonsignificant 26% (RR 0.74; 95% CI: 0.42, 1.3; p-value: 0.281; corresponding to a 3.2% difference in absolute risk) lower likelihood of depressive symptoms than women in control clusters. Study limitations include not using diagnostic interviews to measure depression and not blinding data collectors to intervention status during follow-up. CONCLUSIONS: The Healthy Options intervention did not demonstrate reduction in depressive symptoms at 9 months postpartum, the primary outcome. Significant reductions were seen in depression symptoms at 6 weeks postpartum, the secondary outcome. Stepped-care interventions may be relevant for improving outcomes in the critical early postpartum window. TRIAL REGISTRATION: Clinical Trial registration number (closed to new participants) NCT02039973.

Burden of HIV-related stigma and associated factors among women living with depression accessing PMTCT services in Dar es Salaam, Tanzania.

HIV-related stigma represents a potent risk factor for a range of poor health outcomes, including mental health symptoms, treatment non-adherence, and substance use. Understanding the role of HIV-related stigma in promoting healthcare outcomes is critical for vulnerable populations, such as pregnant women living with HIV, in contexts with continued high rates of HIV and associated stigma, such as sub-Saharan Africa. The current study examined a range of risk and protective factors for HIV-related stigma with 742 pregnant women (M age = 29.6 years) living with depression and HIV accessing prevention of mother-to-child transmission of HIV (PMTCT) services in Dar es Salaam, Tanzania. Risk factors included depressive symptoms, ART non-adherence, intimate partner violence, food insecurity, and alcohol problems. Protective factors included disclosure of HIV status, social support, an appreciative relationship with their partner, hope, and self-efficacy. Findings highlight key psychosocial and behavioral determinants of HIV-related stigma for pregnant women living with HIV in Tanzania, and can inform perinatal care programming and interventions to optimize mental health and adherence outcomes.

Prevalence and factors associated with intimate partner violence after HIV status disclosure among pregnant women with depression in Tanzania.

Intimate partner violence (IPV) exacts a heavy burden on women, resulting in poor health outcomes. This study had the following aims: (1) estimate the prevalence of IPV post-disclosure of HIV status among pregnant women living with HIV and depression; and (2) evaluate risk and protective factors for IPV post-disclosure. Participants were women accessing PMTCT services at 16 health facilities in Dar es Salaam and screened at the threshold of 9 on the PHQ-9. Generalized linear equations with a log link and standard errors clustered at the facility level were used to calculate associations between predictors and IPV post-disclosure. Among 659 women who were in an intimate relationship, 10.2% had experienced physical violence and 11.6% had reported sexual violence from their partner in the past six months; 327 had disclosed their HIV status to their partners. After disclosure to their partners 279 women (85.3%) experienced IPV. HIV-related stigma was associated with increased risk of IPV following disclosure and appreciative relationships with partners and higher hope were associated with reduced risk of IPV. There is a need to identify and advance approaches to HIV disclosure that prevent IPV. Interventions should be developed based on known risk and protective factors for IPV following HIV disclosure in Tanzania and similar settings.

Healthy Options: study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania.

BACKGROUND: Perinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are at an increased risk of depression; however, in Tanzania there is limited access to services provided by mental health professionals. This paper presents a protocol and baseline characteristics for a study evaluating a psychosocial support group intervention facilitated by lay community-based health workers (CBHWs) for perinatal women living with HIV and depression in Dar es Salaam. METHODS: A cluster randomized controlled trial (RCT) is conducted comparing: 1) a psychosocial support group intervention; and 2) improved standard of mental health care. The study is implemented in reproductive and child health (RCH) centers providing PMTCT services. Baseline characteristics are presented by comparing sociodemographic characteristics and primary as well as secondary outcomes for the trial for intervention and control groups. The trial is registered under clinicaltrials.gov (NCT02039973). RESULTS: Among 742 women enrolled, baseline characteristics were comparable for intervention and control groups, although more women in the control group had completed secondary school (25.2% versus 18.2%). Overall, findings suggest that the population is highly vulnerable with over 45% demonstrating food insecurity and 17% reporting intimate partner violence in the past 6 months. CONCLUSIONS: Baseline characteristics for the cluster RCT were comparable for intervention and control groups. The trial will examine the effectiveness of a psychosocial support group intervention for the treatment of depression among women living with HIV accessing PMTCT services. A reduction in the burden of depression in this vulnerable population has implications in the short-term for improved HIV-related outcomes and for potential long-term effects on child growth and development. TRIAL REGISTRATION: The trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered on January 20, 2014.

Stakeholder acceptability of adolescent participation in clinical trials for biomedical HIV prevention products: considerations from Tanzania and India.

Researchers and advocates have increasingly called for adolescent participation in clinical trials for new HIV prevention products, particularly adolescent girls in areas most affected by the epidemic. However, recent trials have highlighted the challenges for young women and adolescents to be able to effectively use new products that require daily dosing. This analysis provides a highly relevant context for this challenging environment by examining community members acceptability of adolescent girls' participation in clinical trials for new HIV prevention products. We conducted 41 in-depth interviews in Dar es Salaam, Tanzania and Pune, India with 22 key informants (KIs). Cultural perspectives on adolescent sexuality varied between countries, with KIs in Tanzania more readily acknowledging adolescent girls' sexual activity than KIs in India. KIs in both countries felt strongly adolescents must be well-informed about research concepts prior to participation, and emphasis should be given to preventative misconception. Despite concern in both countries that the trials might be seen as encouraging sexual behavior, KIs in Tanzania overwhelmingly supported adolescent inclusion, whereas KIs in India were more cautious. Involving adolescent girls in clinical trials for new HIV prevention products is potentially acceptable, although meaningful community engagement will be necessary.

CLINICAL outcomes and loss to follow-up among people living with HIV participating in the NAMWEZA intervention in Dar es Salaam, Tanzania: a prospective cohort study.

BACKGROUND: Psychosocial factors have been linked with loss to follow-up (LTFU) and clinical outcomes among people living with HIV (PLH), however little is known about the effect of psychosocial support on LTFU among PLH in treatment and care. The purpose of this study was to explore the effect of NAMWEZA ("Yes, together we can") friends' psychosocial support intervention on clinical outcomes and LTFU among PLH. NAMWEZA is based on a novel program using "appreciative inquiry", positive psychology approaches to empower, promote positive attitudes and foster hope. METHODS: PLH participating in the NAMWEZA intervention in HIV care clinics in Dar es Salaam Tanzania were compared with non-exposed PLH obtained from facilities that routinely collect clinical information and both followed longitudinally for 24 months. Baseline sociodemographic, clinical measures (CD4 cell count, hemoglobin (HGB), weight), and LTFU measures were collected. Chi square, Fisher's exact tests, and t-tests were used to compare the frequencies for categorical variables and the means of continuous variables from the intervention and the comparison groups to identify variables that were significantly different across the two groups. Random effects models were performed to examine the bivariate associations between the intervention status and clinical outcomes. RESULTS: At the end of 24 months of follow-up mean CD4 count and HGB levels increased significantly in both intervention and comparison groups (p = 0.009 and p < 0.0001, respectively). Weight increased significantly only in the intervention group (p = 0.003). Cumulative LTFU was three times higher in the comparison compared to the intervention (p < 0.001) group. Having a low CD4 count, extremes of weight, low HGB, younger age, and male gender were significantly associated with LTFU among the unexposed group, while being on ART for duration of 12 months or more was protective against LTFU in those intervened. CONCLUSION: Among PLH on ART, exposed or not exposed to NAMWEZA intervention, clinical care outcomes improved over time. LTFU was much higher in the comparison group with factors commonly known to predict LTFU only apparent in the comparison group. NAMWEZA could be a promising peer-facilitated model to reduce LTFU among PLH in care that can be integrated in ART services; however, more research is needed to evaluate its longer term effects.

Domestic violence among adolescents in HIV prevention research in Tanzania: participant experiences and measurement issues.

Under-representation of female adolescents in HIV clinical trials may inhibit their access to future prevention technologies. Domestic violence, broadly defined as violence perpetrated by intimate partners and/or family members, may affect trial participation. This study describes violence in the lives of adolescents and young women in Tanzania, explores use of the Women's Experience with Battering (WEB) Scale to measure battering, and examines the associations between battering and socio-demographic and HIV risk factors. Community formative research (CFR) and a mock clinical trial (MCT) were conducted to examine the challenges of recruiting younger (15-17) versus older (18-21) participants into HIV prevention trials. The CFR included qualitative interviews with 23 participants and there were 135 MCT participants. The WEB was administered in both the CFR and MCT. Nineteen CFR participants experienced physical and/or sexual violence and 17 % scored positive for battering. All married participants reported partner-related domestic violence, and half scored positive for battering. Many believed beatings were normal. None of the single participants scored positive on battering, but one-third reported abuse by relatives. Among MCT participants, 15 % scored positive for battering; most perpetrators were relatives. Younger participants were more likely to report battering. Adolescents experienced high rates of domestic violence and the WEB captured battering from both partners and relatives. The level of familial violence was unexpected and has implications for parental roles in study recruitment. Addressing adolescent abuse in HIV prevention trials and in the general population should be a public health priority.

The value of hope: development and validation of a contextual measure of hope among people living with HIV in urban Tanzania a mixed methods exploratory sequential study.

BACKGROUND: Hope or hopefulness enhances coping and improves quality of life in persons with chronic or incurable illnesses. Lack of hope is associated with depression and anxiety, which impact negatively on quality of life. In Tanzania, where HIV prevalence is high, the rates of depression and anxiety are over four times higher among people living with HIV (PLH) compared to persons not infected and contribute annual mortality among PLH. Tanzania has a shortage of human resources for mental health, limiting access to mental health care. Evidence-based psychosocial interventions can complement existing services and improve access to quality mental health services in the midst of human resource shortages. Facilitating hope can be a critical element of non-pharmacological interventions which are underutilized, partly due to limited awareness and lack of hope measures, adapted to accommodate cultural context and perspectives of PLH. To address this gap, we developed and validated a local hope measure among PLH in Tanzania. METHODS: Two-phased mixed methods exploratory sequential study among PLH. Phase I was Hope-related items identification using deductive, inductive approaches and piloting. Phase II was an evaluation of psychometric properties at baseline and 24 months. Classical test theory, exploratory, confirmatory factor analysis (CFA) were used. RESULTS: Among 722 PLH, 59% were women, mean age was 39.3 years, and majority had primary school level of education. A total of 40 hope items were reduced to 10 in a three-factor solution, explaining 69% of variance at baseline, and 93% at follow-up. Internal consistency Cronbach's alpha was 0.869 at baseline and 0.958 at follow-up. The three-factor solution depicted: positive affect; cognition of effectiveness of HIV care; and goals/plans/ future optimism. Test-retest reliability was good (r = 0.797) and a number of indices were positive for CFA model fit, including Comparative Fit Index of 0.984. CONCLUSION: The developed local hope scale had good internal reliability, validity, and its dimensionality was confirmed against expectations. The fewer items for hope assessment argue well for its use in busy clinical settings to improve HIV care in Tanzania. Hope in this setting could be more than cognitive goal thinking, pathway and motivation warranting more research. TRIAL REGISTRATION: The intervention was registered in USA ClinicalTrials.gov on September 26, 2012, Registration number: NCT01693458.

Improving communication about HIV prevention among people living with HIV and their at-risk social network members in Dar es Salaam, Tanzania.

Although a number of HIV prevention programs have been implemented, such as mass media campaigns, high rates of unprotected and concurrent sexual partnerships, as well as low uptake HIV testing and limited HIV knowledge, persist in Tanzania. We examined the effect and predicting factors of HIV prevention communication among people living with HIV (PLH) exposed to NAMWEZA intervention, and their at-risk social network members (NMs) Quantitative data were collected from 326 participants at baseline and 24 months of follow-up. In-depth interviews with 20 PLH were conducted at follow-up. Results indicated specific communication about condom use and HIV testing increased; (mean increase of 0.28 (SD = 0.14) scores, P = 0.012 and 0.42 (SD = 0.11) scores, p < 0.001 respectively while general discussion about protecting other people from HIV did not change significantly; mean increase was 0.01 scores (SD = 0.005), p = 0.890. Positive predictors of communication included being single; OR = 1.10, p = 0.01, female; OR = 1.15, p = 0.03, aged 30 years or older; OR = 1.23, p < 0.01, HIV knowledge, dose of NAMWEZA participation; OR = 1.01, p < 0.001, and high self-efficacy for condom use; OR = 1.4, p < 0.001. Stigma demonstrated a significant but negative association with communication for condom use; OR = 1.01, p < 0.01.Qualitative data reflected perceived possession of more individual skills and ability to address some personal/cultural obstacles to communicating about HIV prevention including those observed in the quantitative data. NAMWEZA improved communication about HIV prevention among PLH with their at-risk-NMs. The approach is a promising complement to media campaigns in similar populations. Future research and program evaluation efforts should explore how communities perceive and communicate about protecting others from HIV.

Comparing patterns of sexual risk among adolescent and young women in a mixed-method study in Tanzania: implications for adolescent participation in HIV prevention trials.

INTRODUCTION: Despite the disproportionate impact of HIV on women, and adolescents in particular, those below age 18 years are underrepresented in HIV prevention trials due to ethical, safety and logistical concerns. This study examined and compared the sexual risk contexts of adolescent women aged 15-17 to young adult women aged 18-21 to determine whether adolescents exhibited similar risk profiles and the implications for their inclusion in future trials. METHODS: We conducted a two-phase, mixed-method study to assess the opportunities and challenges of recruiting and retaining adolescents (aged 15-17) versus young women (18-21) in Tanzania. Phase I, community formative research (CFR), used serial in-depth interviews with 11 adolescent and 12 young adult women from a range of sexual risk contexts in preparation for a mock clinical trial (MCT). For Phase II, 135 HIV-negative, non-pregnant adolescents and young women were enrolled into a six-month MCT to assess and compare differences in sexual and reproductive health (SRH) outcomes, including risky sexual behaviour, incident pregnancy, sexually transmitted infections (STIs), reproductive tract infections (RTIs) and HIV. RESULTS: In both research phases, adolescents appeared to be at similar, if not higher, risk than their young adult counterparts. Adolescents reported earlier sexual debut, and similar numbers of lifetime partners, pregnancy and STI/RTI rates, yet had lower perceived risk. Married women in the CFR appeared at particular risk but were less represented in the MCT. In addition, adolescents were less likely than their older counterparts to have accessed HIV testing, obtained gynaecological exams or used protective technologies. CONCLUSIONS: Adolescent women under 18 are at risk of multiple negative SRH outcomes and they underuse preventive services. Their access to new technologies such as vaginal microbicides or pre-exposure prophylaxis (PrEP) may similarly be compromised unless greater effort is made to include them in clinical trial research.