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NCT ID: NCT03671239 Not yet recruiting - HIV Prevention Clinical Trials

Rectal Microbicide Acceptability, Tolerability and Adherence

Start date: November 2018
Phase: N/A
Study type: Interventional

MTN-035 is a multi-site, randomized-sequence, three-period, open label crossover study that will enroll approximately 210 participants randomized (1:1:1:1:1:1) to one of six sequences of rectal microbicide placebo product application.

NCT ID: NCT03654898 Not yet recruiting - HIV/AIDS Clinical Trials

VITAL Start: Brief Facility-based Video Intervention

VITAL
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant and breastfeeding women with HIV infection.

NCT ID: NCT03648931 Recruiting - HIV Prevention Clinical Trials

Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa

MAMMA
Start date: May 31, 2018
Phase:
Study type: Observational

The MTN-041 study is a multi-site exploratory study using focus group discussions (FGDs) and in-depth interviews (IDIs) to identify individual, interpersonal, social and cultural factors that may affect potential uptake of two safe and effective HIV prevention products, the monthly dapivirine (DPV) vaginal ring (VR) and daily oral pre-exposure prophylaxis (PrEP), by pregnant and breastfeeding women in Africa.

NCT ID: NCT03555669 Enrolling by invitation - Depression Clinical Trials

Project SOAR-Mental Health Malawi: Depression and HIV Integration

Start date: April 24, 2017
Phase: N/A
Study type: Interventional

Depression is highly prevalent among people living with HIV (PLHIV) in Malawi and elsewhere in sub-Saharan Africa (SSA). Besides its high prevalence, depression likely represents an important barrier to consistent HIV care engagement and long-term viral suppression. However, the potential for depression treatment to improve HIV care outcomes has received little attention in the region, in part because of limited mental health infrastructure. In this study, the investigators will evaluate the impact of a depression treatment program integrated within existing HIV clinics on depression response, retention in HIV care, and viral suppression. It is expected that this evaluation will yield important evidence on the impact of depression treatment integrated with HIV care for improving HIV care and mental health outcomes in Malawi.

NCT ID: NCT03549156 Recruiting - Malnutrition Clinical Trials

Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of MAM.

Start date: June 25, 2018
Phase: N/A
Study type: Interventional

This is a prospective, randomised, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM. The setting will be 21 rural sites in southern Malawi. The participants will be 1800 children 6-59 months old with MAM, defined as mid-upper arm circumference (MUAC) ≥ 11.5 cm and < 12.5 cm and/or a weight-for-height Z-score (WHZ) between -2 and -3 without bipedal edema. Children will receive approximately 75 kcal/kg/d (314 kJ/kg/d) of one of two RUSFs in two-week rations for outpatient therapy of MAM. The two supplements will be a novel, locally produced peanut/dairy RUSFs, one with a high protein quality (HIPRO RUSF) or one with a standard protein quality, referred to as control RUSF (C-RUSF). The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default). Secondary outcome measures include rates of weight, height, and mid-upper-arm circumference (MUAC) gain, time to graduation, and adverse effects from the supplementary foods.

NCT ID: NCT03519425 Not yet recruiting - Hiv Clinical Trials

A Pragmatic Randomised Study to Optimise Screening, Prevention and Care for Tuberculosis in Malawi

PROSPECT
Start date: August 2018
Phase: N/A
Study type: Interventional

A pragmatic open, three-arm individually-randomised controlled trial and economic evaluation will be conducted in one primary health care centre in Blantyre, Malawi, where HIV and TB are major contributors to early mortality. Participants will be adults with symptoms of tuberculosis (cough of any duration) attending the primary clinic with an acute care episode. We will exclude adults who have taken treatment for TB within the previous 6-months, who are taking isoniazid preventive therapy, who are not resident of Blantyre, or who plan to move out of Blantyre in the following 6-months. Participants will be randomly allocated into one of three groups: Group 1: Standard of care: Participants will be seen by facility health workers and receive clinician-directed screening for HIV and TB according to Malawi national guidelines. Group 2: Optimised HIV testing and treatment linkage: Participants will be offered testing for HIV using rapid oral fluid kits by research assistants. Those with confirmed HIV infection will be linked to the HIV care clinic where facility healthworkers will screen for TB using standard sputum-based diagnostics. Group 3: Optimised TB diagnosis, HIV screening and treatment linkage: Participants will receive a high-throughput and high-sensitivity TB screening intervention, in addition to the HIV testing intervention. This will comprise of an initial digital chest x-ray classified by the CAD4TB image-recognition software as either "high probability of TB", or "low probability of TB". Participants whose x-rays are suggestive of TB will receive confirmatory sputum testing with Xpert MTB/Rif Ultra cartridges, whilst participants whose x-rays have a low probability of TB will be referred to facility healthworkers for routine care. All participants will be seen at the health facility at day 56, where they will be tested for HIV (if not on ART) and screened for TB. The Primary Trial Outcome will compare between groups the time to tuberculosis treatment initiation by day 56. The trial is sufficiently powered to permit 3 pairwise comparisons between groups (i.e. Group 1 vs. 2; Group 2 vs. 3; and Group 1 vs. 3). This three-arm pragmatic trial design allows us to efficiently answer two separate, important public health questions: firstly, by comparing Group 2 to Group 1, we should be able to determine whether HIV care should be prioritised for adults with TB symptoms. Additionally, by comparing Group 3 to Group 2, we will provide strong evidence for the effectiveness of an optimised and integrated HIV and TB diagnostic and treatment linkage approach.

NCT ID: NCT03483116 Recruiting - Clinical trials for Rotavirus Infections

A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.

NCT ID: NCT03477279 Recruiting - Hiv Clinical Trials

Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi

Start date: September 25, 2017
Phase: N/A
Study type: Interventional

There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address help address 1) poor male engagement in the HIV continuum of care, 2) low male adoption of biomedical HIV prevention approaches, 3) sub-optimal female engagement in the continuum of care, and 4) poor or uncertain infant outcomes. Our team has developed an intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year.

NCT ID: NCT03422185 Completed - Hypertension Clinical Trials

Understanding Local Determinants of Cardiovascular Disease and Diabetes

Start date: May 2013
Phase:
Study type: Observational

Cross-sectional survey of all adults residing in two defined geographical regions in urban Lilongwe and rural Karonga District. Participants were interviewed, had anthropometric measures taken, and had fasting blood specimens taken.

NCT ID: NCT03399318 Recruiting - Malaria Clinical Trials

Aggressive Antipyretics for Fever Reduction in CNS Malaria

Start date: July 2, 2018
Phase: Phase 2
Study type: Interventional

The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.