Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage.

BACKGROUND: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle. METHODS: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle. RESULTS: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28). CONCLUSIONS: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery. (Funded by the Bill and Melinda Gates Foundation; E-MOTIVE ClinicalTrials.gov number, NCT04341662.).

Essential elements of a community empowerment approach to HIV prevention among female sex workers engaged in project Shikamana in Iringa, Tanzania.

Globally, female sex workers bear a disproportionate burden of HIV, with those in sub-Saharan Africa being among the most affected. Community empowerment approaches have proven successful at preventing HIV among this population. These approaches facilitate a process whereby sex workers take collective ownership over programmes to address the barriers they face in accessing their health and human rights. Limited applications of such approaches have been documented in Africa. We describe the community empowerment process among female sex workers in Iringa, Tanzania, in the context of a randomised controlled trial of a community empowerment-based model of combination HIV prevention. We conducted 24 in-depth interviews with participants from the intervention community and 12 key informant interviews with HIV care providers, police, venue managers, community advisory board members and research staff. Content analysis was employed, and salient themes were extracted. Findings reveal that the community empowerment process was facilitated by the meaningful engagement of sex workers in programme development, encouraging sex worker ownership over the programme, providing opportunities for solidarity and capacity building, and forming partnerships with key stakeholders. Through this process, sex workers mobilised their collective agency to access their health and human rights including HIV prevention, care and treatment.

Project Shikamana: Community Empowerment-Based Combination HIV Prevention Significantly Impacts HIV Incidence and Care Continuum Outcomes Among Female Sex Workers in Iringa, Tanzania.

OBJECTIVE: To determine the impact of a community empowerment model of combination HIV prevention (Project Shikamana) among female sex workers (FSW) in Iringa, Tanzania. METHODS: We conducted a 2-community randomized trial. Intervention elements included the following: (1) Community-led drop-in center and mobilization activities; (2) venue-based peer education, condom distribution, and HIV testing; (3) peer service navigation; (4) provider sensitivity trainings; and (5) SMS reminders. We used time-location sampling to enroll 496 FSW and conducted a survey and blood draws to screen for HIV and assess viral load at 0 and 18 months. We conducted an intent-to-treat analysis using logistic and Poisson regression and inverse probability weighting for primary outcomes. RESULTS: The analysis included 171 HIV-positive and 216 HIV-negative FSW who completed baseline and 18-month study visits. Participants in the intervention were significantly less likely to become infected with HIV at 18-month follow-up (RR 0.38; P = 0.047), with an HIV incidence of 5.0% in the intervention vs. 10.4% control. Decreases in inconsistent condom use over time were significantly greater in the intervention (72.0%-43.6%) vs. control (68.8%-54.0%; RR 0.81, P = 0.042). At follow-up, we observed significant differences in behavioral HIV care continuum outcomes, and positive, but nonsignificant, increases in viral suppression (40.0%-50.6%) in the intervention vs. control (35.9%-47.4%). There was a strong association of between higher intervention exposure and HIV outcomes including viral suppression. CONCLUSIONS: Project Shikamana is the first trial of community empowerment-based combination prevention among FSW in Africa to show a significant reduction in HIV incidence warranting its broader implementation and evaluation.

Community Savings Groups, Financial Security, and HIV Risk Among Female Sex Workers in Iringa, Tanzania.

This study assessed the association between community savings group participation and consistent condom use (CCU) among female sex workers (FSW) in Iringa, Tanzania. Using cross-sectional data from a survey of venue-based FSW (n = 496), logistic regression was used to examine the associations between financial indicators including community savings group participation and CCU. Over one-third (35%) of the women participated in a savings group. Multivariable regression results indicated that participating in a savings group was significantly associated with nearly two times greater odds of CCU with new clients in the last 30 days (aOR = 1.77, 95% CI 1.10-2.86). Exploratory mediation analysis indicated that the relationship between savings group participation and CCU was partially mediated by financial security, as measured by monthly income. Findings indicate that community savings groups may play an important role in reducing sexual risk behaviors of FSW and hold promise as part of comprehensive, community-led HIV prevention strategies among FSW.

Social and structural factors related to HIV risk among truck drivers passing through the Iringa region of Tanzania.

Truck drivers and their assistants have been identified as groups at higher risk for HIV infection. We sought to identify and describe the social and structural factors that may contribute to HIV risk among truck drivers who visit rest stops in Iringa, Tanzania, a region characterized by high levels of migration and mobility. This analysis was part of a comprehensive strategic assessment to examine HIV risk factors in Iringa. This analysis focuses on 11 in-depth interviews with truck drivers and a transport owner. A semi-structured interview guide was developed to elicit open-ended responses and enable probing. Interviews were conducted in Swahili, transcribed, and translated into English. Data analysis followed thematic analysis procedures that included initial reading of transcripts, development of a codebook and identification of themes through in-depth reading of transcripts. Drivers described structural risk factors for HIV including work conditions, the power imbalance between male drivers and their sexual partners and minimal perceived HIV risk with certain partners (e.g., regular partners and women selling sex). Multiple and inter-related social norms associated with truck stop environments influenced HIV risk, including peer influence and expectations, presence of sex workers, ability to purchase sex throughout their travel and alcohol consumption. These distinct social norms in truck stops and other rest points facilitated behavior that many participants said they would not engage in elsewhere. HIV prevention strategies with truck drivers should address individual, social and structural barriers to HIV prevention through partnerships with the health and transportation sectors, local government and local communities. HIV prevention services should be adapted to drivers' times and places of availability, for example, condom provision where/when drivers make decisions about or have sex. A focus on positive messaging and addressing specific challenges including the continual challenge of re-choosing and reinforcing decisions to engage in safer sexual behaviors is important.

Project Shikamana: Baseline Findings From a Community Empowerment-Based Combination HIV Prevention Trial Among Female Sex Workers in Iringa, Tanzania.

BACKGROUND: Community empowerment approaches have been found to be effective in responding to HIV among female sex workers (FSWs) in South Asia and Latin America. To date, limited rigorous evaluations of these approaches have been conducted in sub-Saharan Africa. METHODS: A phase II community randomized controlled trial is being conducted in Iringa, Tanzania, to evaluate the effectiveness of a community empowerment-based combination HIV prevention model (Project Shikamana) among a stratified sample of HIV-infected and HIV-uninfected FSWs. Cohort members were recruited from entertainment venues across 2 communities in the region using time-location sampling. All study participants gave consent, and were surveyed and screened for HIV at baseline. Primary biological study outcomes are viral suppression among the HIV-infected and remaining free of HIV among HIV-uninfected women. RESULTS: A cohort of 496 FSWs was established and is currently under follow-up. Baseline HIV prevalence was 40.9% (203/496). Among HIV-infected FSWs, 30.5% (62/203) were previously aware of their HIV status; among those who were aware, 69.4% were on antiretroviral therapy (43/62); and for those on antiretroviral therapy, 69.8% (30/43) were virally suppressed. Factors associated with both HIV infection and viral suppression at baseline included community, age, number of clients, and substance use. Amount of money charged per client and having tested for sexually transmitted infection in the past 6 months were protective for HIV infection. Social cohesion among FSWs was protective for viral suppression. CONCLUSIONS: Significant gaps exist in HIV service coverage and progress toward reaching the 90-90-90 goals among FSWs in Iringa, Tanzania. Community empowerment approaches hold promise given the high HIV prevalence, limited services and stigma, discrimination, and violence.

"I pray that they accept me without scolding:" experiences with disengagement and re-engagement in HIV care and treatment services in Tanzania.

HIV care and treatment programs in sub-Saharan Africa have been remarkably successful, but disengagement from care by people living with HIV (PLHIV) remains high. The goal of this study was to explore the experiences of PLHIV who disengaged from HIV care in Iringa, Tanzania. We conducted a series of three longitudinal, semi-structured interviews with 14 PLHIV who had disengaged from ART programs for a total of 37 interviews. Narrative analysis was used to identify key themes. Our findings indicate that an individual's decision to disengage from care often resulted from harsh and disrespectful treatment from providers following missed appointments. Once disengaged, participants reported a strong desire to re-engage in care but also reluctance to return due to fear of further mistreatment. Participants who successfully re-engaged in care during the course of this study leveraged social support networks to facilitate this process, but often felt guilt and shame for breaking clinic rules and believed themselves to be at fault for disengagement. Developing strategies to minimize disengagement and facilitate re-engagement through more flexible attendance policies, improved client-provider interactions, and outreach and support for disengaged clients could increase retention and re-engagement in HIV care and treatment programs.