Fred Ssewamala
ID: UNCST-2020-R014060
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Youth Health SMS: Using mobile technology to prevent HIV and related Youth Health problems: Sexual health, Mental health, and Substance use in southwest Uganda
REFNo: SS969ES
This study will result in the development of one of the first mobile phone-based interventions for Adolescents and Young Adults (AYA) in East Africa that begins to address the co-morbid HIV risk factors of sexual health, mental health, and alcohol use. AYA is a developmental period associated with the increased importance of peers, increased technology use, increased mobility, initiation of sex, emergence of mental health disorders (if at risk), and initiation of alcohol use. Consequently, AYA is a critical time for preventive interventions. Poor mental health and alcohol abuse are associated with increased risk for HIV infection. Thus, the proposed research will attempt to address these areas concurrently.
The proposed research will evaluate if adapting and updating the existing free and nationally available text message and interactive voice recognition (IVR) service included in *161 that was initially developed by FHI 360. Our work will test and tailor messages for AYA to disseminate pre-exposure prophylaxis (PrEP) information and pilot specific mental health and hazardous alcohol use screens. Symptomatic AYA will be referred to behavioral health counselors for further assessment and treatment as needed. AYA today rely heavily on mobile phones for information and services, thus we believe the proposed intervention could be applied and adapted across the region, and potentially in other under-resourced settings.
We will conduct formative research to evaluate and adapt an existing text-message and interactive voice recognition (IVR) platform. We will then pilot the new menus and examine if using this platform promotes HIV prevention (pre-exposure prophylaxis (PrEP), HIV testing, safer sexual behaviors) and increases mental health and alcohol use screening and linkage to counselors as needed for adolescents and young adults (AYA) in a rural Ugandan region with high HIV seroprevalence and limited resources.
2. State the study objective(s) and research question(s)
Aim 1: To adapt an evidence-based mobile phone-delivered sexual health program, to include PrEP information and deliver mental health and alcohol use assessments with the goal of increasing screening and referral, as well as linkage to counselors for AYA at HIV risk.
Aim 2: Evaluate through a pilot RCT (N=126 AYA, 15-19 years) intervention (a) acceptability and feasibility, and (b) impact on uptake of HIV prevention strategies, as well as screening and linkage to mental health and alcohol use school-based counselors.
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Masaka, Kimaanya
Kalungu, Kabukunge
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Uganda |
2021-10-12 |
2024-10-12 |
164 |
There will be two phases to the study. The first will be approximately three months and include 24 male and female AYA (15-19) years. The second phase will include 140 male and female (15-19 years). |
National Institute of Mental Health (NIMH) |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
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Christine Wiltshire Sekaggya
ID: UNCST-2019-R000578
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Clinical Predictors of 3-Months Isoniazid Rifapentine (3HP)- Related Adverse Drug Reactions (ADR) During Tuberculosis Preventive Therapy
(PAnDoRA-3HP study)
REFNo: HS1582ES
Primary Objectives
1.To describe the safety profile of 3HP among people receiving tuberculosis preventive therapy.
2.To describe the effect of adverse drug reactions on tuberculosis preventive therapy completion rates
Secondary Objective
1.To describe the pharmacokinetic and pharmacogenomic determinants of ADRs among people receiving tuberculosis preventive therapy in Uganda
2.To determine the efficacy of 3HP when used for tuberculosis preventive therapy.
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Kampala, Mulago III
Kampala, Kisenyi
Kampala, Kasubi
Kampala, Nakawa I
Jinja, Magwa
Mubende, Mubende Town Council
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Uganda |
2021-10-04 |
2024-10-04 |
614 |
Patients will be included in the study if they meet the following inclusion criteria:
1. Individuals of any age who have been initiated on TPT using the isoniazid/rifapentine regimen according to standard of care
2. Both PLWHIV and HIV-uninfected indivi |
National Institution of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Joseph Lutaakome
ID: UNCST-2020-R008323
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An International Multicenter, Randomized, Double-Blind, PlaceboControlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
REFNo: HS1715ES
Primary Objective
Primary objective: Among outpatients with recently diagnosed SARS-CoV-2 infection to compare the safety and efficacy of a single infusion of hIVIG (pooled for the 2 hIVIG
products) versus placebo, each given with SOC, on clinical status after seven days. Two hypotheses will be tested to address this primary objective, which compares the primary endpoint among two study populations: 1) participants where neutralizing MAb was not specified as part of SOC treatment (stratum 1, see Section 6.1 Overall Study Design); and 2) all randomized participants (stratum 1 and stratum 2 combined). hIVIG will be considered superior to placebo if either of the two hypotheses are rejected.
Secondary Objectives and Endpoints
Secondary objectives, including subgroup analyses and safety outcomes, will be addressed for all randomized participants and for those in stratum 1 and 2 separately.
Secondary Endpoints
The clinical status as classified on the ordinal outcome scale will be assessed with a number of additional analyses comparing hIVIG (pooled for the 2 hIVIG products) with placebo, among the overall study population as well as for the key subgroup of those not receiving anti-SARS-CoV-2 monoclonal antibodies as part of SOC (stratum 1), including:
1. All-cause hospitalization or death through 28 days.
2. All-cause mortality through 28 days.
3. Significant disease progression through 28 days, using a time to event analysis with outcome defined by fulfilling criteria for category 4 or 5 on the ordinal scale.
4. Distribution of ordinal scale outcome at Day 4, 14, and 28.
5. The proportion of participants with any disease progression at Day 7, using a sliding dichotomous scale progression defined by a categorization on the ordinal scale that is worse than the status at entry
|
|
Uganda |
2021-10-04 |
2024-10-04 |
A sample size for this phase 3 trial of 820 participants is planned, which would consist of at least 656 participants in stratum 1. |
In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria prior to randomization:
i. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an
ii. immunosuppressed condition.
|
The study is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, through their contract organization Leidos. There is a subcontract between the University of Minnesota (the Sponsor) and the MRC CTU at UCL. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Lukia Namaganda Hamid
ID:
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Malnutrition as a probable predictor of mortality in cerebral palsy (CP), and the effect of positive deviance and parent facilitator training strategies to malnutrition and caregiving among children and adolescents with CP in the Iganga, Mayuge and Bugweri rural districts of eastern Uganda
REFNo: HS1427ES
Specific Objectives:
1. To assess mortality and whether malnutrition is one of the predictors among a population based sample of children and adolescents with cerebral palsy the Iganga Mayuge-Health and Demographic Surveillance Site (IM-HDSS), Uganda
2. To assess the difference in the change in nutritional status in 2015 and 2019 among children with CP compared to their age and sex matched controls without CP at the IM-HDSS, Uganda.
3. To explore positive and negative nutrition practices among caregivers of well-nourished and under-nourished children with cerebral palsy respectively at the IM-HDSS, Uganda.
4. To determine the difference in the effectiveness of the positive deviance strategy and parent facilitator trainings on CP child and adolescent malnutrition and caregiving within the Iganga, Mayuge and Bugweri districts, Uganda.
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Iganga,
Mayuge,
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Uganda |
2021-09-29 |
2024-09-29 |
126 for the RCT |
Caregivers of children and adolscents with Cerebral aged 2-21 years old |
Cerebral Palsy in Uganda Project (CURIE), Makerere University School of Public Health, Department of Epidemiology and Biostatistics |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
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Isaac Ssewanyana
ID: UNCST-2020-R014336
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Evaluation of the performance of the Salmonella Biolineâ„¢ typhi IgG/IgM Fast test in a near-patient testing environment, including evaluation of usability
REFNo: HS1700ES
To evaluate the usability of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in the near-patient environment using a questionnaire based survey. ,To establish the performance of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in a near-patient setting compared to the performance in a professional lab (i.e. Central Public Health Laboratory) using venous whole blood samples. ,
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pakwach,
Kampala, Kiruddu
Kampala, kisenyi
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Uganda |
2021-09-29 |
2024-09-29 |
80 |
• Male and female patients above 18 years seeking treatment from selected health units who are able to give consent to the study meeting the selection criteria. |
ABBOTT KOREA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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