There are about 14 clinical studies being (or have been) conducted in Lesotho. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients. The objectives are to measure patient retention, virological suppression, provider and patient costs, cost-effectiveness, and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models, and to compare these to patients who receive ART directly from the clinic at three month intervals. Methods A prospective, parallel, cluster-randomized non-inferiority trial with three study arms will be conducted. 30 Clusters (sites) will be randomized in strata according to geographic location (urban and rural) to the 3 study arms as follows: - Control arm: sites at which patients will receive three monthly ART supply at the facility (arm 3MF). - Intervention arm 1: sites at which patients will receive three monthly ART supply in CAGs (arm 3MC) - Intervention arm 2: sites at which patients will receive six monthly ART supply in the community by a healthcare worker (arm 6MCD). The study population will consist of stable, HIV-infected adults who have received first-line ART for at least six months, who have a viral load <1000 copies/ml at baseline, and who provide informed consent for inclusion in the study. An average of 192 participants from each study site will be included, with a total sample size of approximately 5760 participants. The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment, with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm. Retention in care will also be compared between the three arms after 24 months. The secondary outcomes are: - Viral suppression: defined as the proportion of patients with virological suppression (<1000 copies/ml) 12 and 24 months after study enrolment; - Cost of providing ART: defined as the cost per patient of providing ART in each of the three arms (from a provider perspective); - Cost of retaining a patient: defined as the provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms, and the incremental cost-effectiveness ratio for the comparative arms.
This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.
In the era of test-and-treat, with anticipated high numbers of patients who will have unsuppressed viral load (VL) due to poor adherence, simple, short and standardized adherence interventions with documented efficacy will be needed. Achieving re-suppression in patients with unsuppressed VL is beneficial for the health of the individual, important to reduce the risk of transmission and has a direct cost implication because patients with sustained unsuppressed VL will ultimately be switched to more expensive 2nd-line regimens. Information is still largely lacking on how to best address adherence problems among patients with unsuppressed VL. VL monitoring is recognized as a useful tool to reinforce adherence in patients with unsuppressed VL. The Lesotho Guidelines recommend redoing a VL 8-12 weeks after the first enhanced adherence counselling. To date no study has been published clearly demonstrating higher re-suppression rates after enhanced adherence counselling for patients with unsuppressed VL. This project aims to test an adherence intervention for HIV-positive individuals on first-line ART who have an unsuppressed viral load. A step wedged study will be used to compare the effectiveness of a short, standardized adherence counselling followed by an SMS reminder to the standard of care (≥ 2 unstructured adherence counselling sessions) in terms of viral re-suppression rates and switches to 2nd line ART.
This trial addresses the question of the viral load (VL) threshold for switching from first-line to second-line antiretroviral therapy (ART). The WHO currently sets the threshold at 1000 copies/mL. However, the optimal threshold for defining virological failure and the need to switch ART regimen has not been determined. In fact, people with VL levels of less than 1000 copies/mL, however, not fully suppressed, are at increased risk for drug resistance mutations (DRM) and subsequent virological failure. In resource-limited settings where VL monitoring is not as frequent as in high-income countries, this could have serious implications and patients may continue on a failing regimen for a long period. Our research consortium will conduct a multicenter, parallel-group, open-label, randomized clinical trial in a resource-limited setting to assess whether a threshold of 100 copies/mL compared to the WHO-defined threshold of 1000 copies/mL for switching to second-line ART among unsuppressed HIV-positive patients on first-line ART will lead to better outcomes.
endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).
The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural Lesotho. Participants who were tested HIV-positive during community-based HIV testing and counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1 with parallel assignment. Participants in the control arm follow the standard of care after a community-based HIV test result: They are referred to the nearest clinic where they will receive baseline laboratory testing and adherence counseling. After at least 2 clinic visits for adherence counseling they can start anti-retroviral therapy (ART). After ART-initiation they have to attend monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention arm are proposed same day community-based ART initiation combined with less frequent follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression at 12 months after having tested HIV-positive during the community-based HIV testing and counseling campaigns.
Lesotho, a small, landlocked country completely surrounded by South Africa, is among the world's poorest nations with one of the world's most severe epidemics of tuberculosis (TB) and HIV. TB incidence is the world's highest and approximately 76% of TB patients are HIV coinfected. Data from similar settings suggest that TB incidence in children is approximately 50% of adult TB incidence. The Lesotho National TB Program has adopted World Health Organization's (WHO) isoniazid preventive therapy (IPT) recommendations for child contacts; however, as in other countries in the region, implementation of IPT in children is limited, no clear strategies guide child contact tracing and screening, and no clear methods ensure provision of IPT in children. Thus, it is important to evaluate novel methods to prevent TB in child contacts of adult TB cases. The purpose of the PREVENT Study is to identify an effective and acceptable intervention that addresses programmatic, structural and psychosocial barriers to contact tracing, screening, and IPT for child contacts of TB patients, with the ultimate goal of improving health outcomes among children in Lesotho. The study is a two-arm cluster randomized trial, randomized at the TB clinic level, which includes ten TB clinics in Berea district. Clinics are randomized to deliver the community-based intervention (CBI) or standard of care (SOC), with stratification by facility type. The experimental intervention will be delivered to all child contacts of adult TB patients in TB clinics randomly assigned to CBI. In TB clinics assigned to SOC, usual care procedures for contact tracing and IPT will be delivered.
The specific objectives of this study are reduce stigma towards lesbian, gay, bisexual, and transgender persons in Swaziland and Lesotho, using performance ethnography at community roundtables.
This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic treatment failure as well as chronic communicable and non-communicable comorbidities among patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to determine prevalence of treatment failure as well as the prevalence of the following comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with treatment failure or a comorbidity or both are followed-up for 12 months.
The purpose of this study is to gather information needed to develop a large prevention trial to decrease the risk for HIV transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIVnegative) in Lesotho. The protocol team would like to learn more about men, women and couples in Lesotho and what they think about various topics related to HIV, including HIV testing and counseling, male circumcision and HIV treatment. There will be three parts to the study including 1) a survey 2) focus group discussions; and 3) in-depth interviews. Two hundred pregnant or recently postpartum women will be recruited to participate in the survey. Women who answer the questionnaire will also be asked to participate in the focus groups. A total of 6-8 groups consisting of 6-12 women each will be conducted. Thirty men from the community will be recruited to participate in an in-depth individual interview.