Beira

This research aims to improve HIV healthcare for mothers living with HIV and their newborns in Tanzania and Mozambique, focusing on preventing HIV transmission from mother to child. The study evaluates whether adding maternal HIV viral load testing at delivery better identifies mother-child pairs at high risk of transmission and whether high-risk infants receive appropriate prevention and care. It builds on previous findings about early infant HIV treatment challenges and seeks to reduce access inequities in rural areas by expanding HIV testing services through a hub-and-spoke referral system. The study involves maternal HIV viral load testing at delivery to assess vertical HIV transmission risk, combined with WHO clinical criteria for risk classification. The intervention includes personnel support for managing high-risk cases, eHealth tools for sharing test results between health facilities, and enhanced counseling for high-risk mother-baby pairs. High-risk infants and their mothers are followed long-term for up to 12 months to monitor health outcomes and treatment adherence. Participants will undergo HIV testing at birth and follow-up visits at 4-6 weeks, 14 weeks, 6 months, and 12 months, with assessments of viral suppression, drug resistance, and clinical outcomes. The study also collects socio-behavioral data through interviews and questionnaires to understand factors affecting treatment outcomes. Researchers will measure key program indicators such as the proportion of high-risk newborns tested and started on treatment within seven days, turnaround times for testing, and cost-effectiveness of the intervention package. Continuous support and counseling are provided throughout the study duration.

Researchers are studying people living with HIV-1 infection who are on dolutegravir DTG-based antiretroviral therapy ART but have a viral load above 1,000 copiesmL after at least six months of treatment. The goal is to understand viral suppression rates and the emergence of DTG-associated drug-resistant mutations in these individuals. This multi-country prospective observational study takes place in Kenya, Mozambique, Tanzania, and Lesotho, addressing gaps in data about managing virologic failure without changing the ART regimen. Participants will continue their DTG-based ART for up to 12 months while receiving enhanced adherence counseling if their viral load remains above 200 copiesmL. Study visits and viral load testing happen at enrollment and every three months during the active follow-up period. Enhanced adherence counseling includes at least three sessions per visit to support medication adherence and address other causes of viral increase. The study also collects routine program data for up to 24 months to assess how well viral suppression lasts over time. During the study, participants undergo viral load testing, counseling, and assessments at regular intervals. Researchers will analyze viral suppression rates at 6 and 12 months and evaluate factors that predict suppression or the development of drug resistance. They will also monitor the patterns and timing of drug-resistant mutations and opportunistic infections. The study plans to enroll 6,600 participants and may invite eligible individuals to join a nested randomized clinical trial focusing on managing drug resistance.

Researchers are studying the management of drug resistance in people living with HIV who are on dolutegravir DTG-based antiretroviral therapy but experience treatment failure due to drug-resistant mutations. This phase 3b randomized clinical trial aims to compare the effectiveness and safety of continuing DTG versus switching to ritonavir-boosted darunavir DRVr in patients with HIV-1 RNA levels above 200 copiesmL and at least one major DTG-associated drug resistance mutation. The study addresses gaps in current treatment strategies across several countries. Participants will be randomly assigned to one of two groups one will continue their existing DTG-based ART regimen, and the other will switch to a DRVr-based ART regimen. The dosing will be based on weight, and the study will take place over 12 months at multiple sites in Kenya, Mozambique, Tanzania, and Lesotho. The primary measure is the proportion of participants achieving viral suppression with HIV-1 RNA below 200 copiesmL at 6 months. During the trial, participants will have regular monitoring of their viral load and drug resistance mutations, along with assessments of treatment adherence, safety, and patient satisfaction. Additional outcomes include viral suppression rates at 12 months, incidence of adverse events, and changes in CD4 counts. The study includes children aged 3 years and older and plans to enroll 392 participants. Follow-up and data collection will support understanding optimal treatment management for this population.

This research aims to evaluate the effectiveness and implementation of suicide safety planning and a transdiagnostic cognitive behavioral therapy CBT intervention to reduce suicidal behaviors among secondary school students in Mozambique. The study addresses the urgent need for adolescent suicide prevention in low- and middle-income countries, particularly in Mozambique where suicide rates among youth are notably high. The project builds on prior work demonstrating feasibility and initial effectiveness of these interventions delivered by non-specialists in Mozambique. Participants will be enrolled from 21 secondary schools randomized into three groups Enhanced Usual Care EUC, Safety Planning Intervention SPI, and Transdiagnostic Cognitive Behavioral Therapy for Suicide Prevention TCBT-S. EUC involves screening and referral to government mental health services. SPI includes a stepwise safety plan tailored to the individual focusing on coping and crisis prevention. TCBT-S combines SPI with psychoeducation, cognitive restructuring, activity linking, problem solving, and relaxation techniques delivered over 6-8 weekly sessions by trained non-specialists. Youth participation includes suicide risk screening, development of safety plans, therapy sessions for those in the TCBT-S group, and follow-up assessments at 2, 3, 4, 6, 12, and 24 months post-intervention. Researchers will measure suicidal behaviors as the primary outcome at 6 months and secondary outcomes including suicidal ideation and depressive symptoms at multiple time points. The study also examines implementation outcomes, costs, and cost-effectiveness to inform future scale-up efforts in Mozambique and similar settings.