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NCT ID: NCT03176914 Recruiting - Pneumonia Clinical Trials

Testing the Effectiveness of a Modified Community Model in Improving Child Health Outcomes in Mashonaland East, Zimbabwe

Start date: January 19, 2017
Phase: N/A
Study type: Interventional

This study modified and contextualized a community mobilization approach in a bid to find a solution to reduce the high incidence and prevalence of child morbidity and mortality in Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity and mortality at community level by comparing the effect of the intervention to that of the conventional community interventions.

NCT ID: NCT03122223 Not yet recruiting - HIV Infections Clinical Trials

Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®-or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants

HVTN120
Start date: June 5, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants

NCT ID: NCT03119337 Not yet recruiting - Clinical trials for Voluntary Medical Male Circumcision

Text-based Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program

2WT
Start date: September 2017
Phase: N/A
Study type: Interventional

Voluntary medical male circumcision (VMMC) in sub-Saharan Africa is safe: the average rate of moderate and severe adverse events (AEs) at the country level is 0.8%, corresponding to 99% of men healing without incident. To reach the global target of 20 million by 2018, VMMC productivity needs to double in countries already plagued by severe healthcare worker shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health and Child Care (MoHCC) and performed over 120,000 VMMCs. Current VMMC care in Zimbabwe requires in-person, follow-up visits at post-operative days 2,7, and 42. Over 95% adhere to multiple follow-up visits within 14 days of VMMC. ZAZIC's program has an overall AE rate of 0.4%; therefore, overstretched clinic staff conducted more than 200,000 unnecessary reviews for VMMC clients without complications. High mobile phone ownership, severe healthcare worker shortages, and rapid VMMC scale up make ZAZIC's VMMC program an ideal setting to test a mobile health (mHealth) intervention to reduce provider workload while safeguarding patient safety. Through an un-blinded, prospective, randomized, control trial (RCT) in high-volume facilities providing VMMC, ZAZIC will implement an interactive, two-way texting (2wT) intervention to identify men healing without complication, allowing them to decline routine in-person follow up visits. 2wT will simultaneously identify men with any sign of an adverse event, encouraging rapid in-person follow-up when an AE is suspected on any day, reducing unnecessary visits while maintaining quality care. We aim to 1) determine if 2wT can safely reduce VMMC follow-up visits; 2) estimate the cost savings associated with 2wT over routine VMMC follow-up; and 3) assess the acceptability and feasibility of 2wT for further scale-up. It is expected that this intervention with be as safe as routine care while providing distinct advantages in terms of efficiency, costs, and reduced healthcare worker burden. This approach is innovative as it focuses on using a low-cost mHealth intervention to reduce provider workload without deterioration in quality care. The success of this intervention could lead to adoption of this intervention at the national level, increasing efficiency of VMMC scale up and reducing burdens on providers and patients

NCT ID: NCT03060629 Not yet recruiting - HIV-1 Clinical Trials

A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

Start date: November 1, 2017
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.

NCT ID: NCT03049176 Recruiting - HIV Infections Clinical Trials

The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)

SAFER
Start date: March 13, 2017
Phase: N/A
Study type: Observational

This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

ASOS
Start date: February 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.

NCT ID: NCT03017872 Not yet recruiting - HIV Infections Clinical Trials

Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

D²EFT
Start date: July 2017
Phase: Phase 4
Study type: Interventional

D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares a novel regimen of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir) with the WHO recommended regimen of 2(t)NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 610 participants from 10 predominantly low-middle income countries will be followed for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that the new regimen will be non-inferior to SOC in terms of virologic control while being easier to take, economically viable and affording simplification of treatment programs.

NCT ID: NCT02833441 Recruiting - HIV Clinical Trials

The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes

PESU
Start date: July 2016
Phase: N/A
Study type: Interventional

Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression.

NCT ID: NCT02732730 Recruiting - HIV Clinical Trials

Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study

Start date: October 2016
Phase: Phase 4
Study type: Interventional

To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.

NCT ID: NCT02702895 Not yet recruiting - HIV Prevention Clinical Trials

Assessment of ASPIRE and HOPE Adherence

Start date: June 2016
Phase: N/A
Study type: Observational

MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore socio-contextual and trial specific issues which affected participants' adherence to the dapivirine vaginal ring (VR).