Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti.

BACKGROUND: Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population. METHODS AND FINDINGS: We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. CONCLUSIONS: In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov NCT03154320.

An Adapted Self-screening Tool for Peripartum Cardiomyopathy in Haiti.

BACKGROUND: Peripartum cardiomyopathy (PPCM) is considered rare in the United States; however, the literature notes that the disease has a higher prevalence in developing countries such as Haiti. Dr. James D. Fett, a US cardiologist, developed and validated a self-assessment measure for PPCM in the United States to aid women to easily differentiate the signs and symptoms of heart failure from those related to a normal pregnancy. Although this instrument was validated, it lacks the adaptation necessary to account for the language, culture, and education of the Haitian population. OBJECTIVE: The aim of this study was to translate and culturally adapt the Fett PPCM self-assessment measure for use among a Haitian Creole speaking population. METHODS: A preliminary Haitian Creole direct translation was developed from the original English Fett self-test. A total of four focus groups with medical professionals and 16 cognitive interviews with members of a community advisory board were conducted to refine the preliminary Haitian Creole translation and adaptation. RESULTS: The adaptation focused on incorporating cues that would be tangible and connected to the reality of the Haitian population while maintaining the intended meaning of the original Fett measure. CONCLUSIONS: The final adaptation provides an instrument suitable for administration by auxiliary health providers and community health workers to help patients distinguish symptoms of heart failure from symptoms related to normal pregnancy and further quantify the severity of signs and symptoms that might be indicative of heart failure.

Perceptions of isolation during facility births in Haiti - a qualitative study.

BACKGROUND: Haiti's maternal mortality, stillbirth, and neonatal mortality rates are the highest in Latin America and the Caribbean. Despite inherent risks, the majority of women still deliver at home without supervision from a skilled birth attendant. The purpose of this study was to elucidate factors driving this decision. METHODS: We conducted six focus group discussions with women living in urban (N = 14) or rural (N = 17) areas and asked them questions pertaining to their reasons for delivering at a facility or at home, perceptions of staff at the health facility, experiences with or knowledge of facility or home deliveries, and prior pregnancy experiences (if relevant). We also included currently pregnant women to learn about their plans for delivery, if any. RESULTS: All of the women interviewed acknowledged similar perceived benefits of a facility birth, which were a reduced risk of complications during pregnancy and access to emergency care. However, many women also reported unfavorable birthing experiences at facilities. We identified four key thematic concerns that underpinned women's negative assessments of a facility birth: being left alone, feeling ignored, being subject to physical immobility, and lack of compassionate touch/care. Taken together, these concerns articulated an overarching sense of what we term "isolation," which encompasses feelings of being isolated in the hospital during delivery. CONCLUSION: Although Haitian women recognized that a facility was a safer place for birthing than the home, an overarching stigma of patient neglect and isolation in facilities was a major determining factor in choosing to deliver at home. The Haitian maternal mortality rate is high and will not be lowered if women continue to feel that they will not receive comfort and compassionate touch/care at a facility compared to their experience of delivering with traditional birth attendants at home. Based on these results, we recommend that all secondary and tertiary facilities offering labor and delivery services develop patient support programs, where women are better supported from admission through the labor and delivery process, including but not limited to improvements in communication, privacy, companionship (if deemed safe), respectful care, attention to pain during vaginal exams, and choice of birth position.

Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

BACKGROUND: Attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression. METHODS AND FINDINGS: We conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic infections (GHESKIO) Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1) to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44%) participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52%) had <1,000 copies/ml; 20 participants (6%) died. In the same-day ART group, 184 (53%) participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61%) had <1,000 copies/ml; 10 (3%) participants died. The unadjusted risk ratio (RR) of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015) for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. CONCLUSIONS: Same-day HIV testing and ART initiation is feasible and beneficial in this setting, as it improves retention in care with virologic suppression among patients with early clinical HIV disease. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov number NCT01900080.