Positive Deviance to Improve Retention in HIV Care HIV Care in South Africa
Conditions: Hiv Interventions: Behavioral: Connect Sponsors: RAND; National Institute of Mental Health (NIMH); University of Stellenbosch; Western Cape Department of Health and Wellness Enrolling by invitation (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 5, 2023 Category: Research Source Type: clinical trials

Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): study protocol for an adaptive randomized controlled trial
DiscussionThis trial will evaluate the contribution of different modes of adherence support on MDR-TB and HIV outcomes with WHO-recommended all-oral MDR-TB regimens and ART in a high-burden operational setting. We will also assess the utility of a DSD framework to pragmatically adjust levels of MDR-TB and HIV treatment support.Trial registrationClinicalTrials.gov NCT05633056. Registered on 1 December 2022 (Source: Trials)
Source: Trials - December 1, 2023 Category: Research Source Type: clinical trials

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa
Conditions: HIV Infections Interventions: Drug: Cabotegravir Injection [Apretude]; Drug: Tenofovir disoproxil fumarate / emtricitabine (or lamivudine) Sponsors: University of Witwatersrand, South Africa; ViiV Healthcare; Bill and Melinda Gates Foundation Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 18, 2023 Category: Research Source Type: clinical trials

Vaginal lIve Biotherapeutic RANdomized Trial
Conditions: Bacterial Vaginosis Interventions: Drug: LC106; Drug: LC115; Drug: Placebo; Drug: Metronidazole Oral Sponsors: Massachusetts General Hospital; Bill and Melinda Gates Foundation; Ragon Institute of MGH, MIT and Harvard; Centre for the AIDS Programme of Research in South Africa Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 16, 2023 Category: Research Source Type: clinical trials

Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
Conditions: Sexually Transmitted Infections (Not HIV or Hepatitis); Premature Birth; Pregnancy; Infection; Microbial Colonization; Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection; Trichomonas Vaginitis; Mycoplasma Genitalium Infection; Bacterial Vaginosis; Vaginal Candida; Ureaplasma Urealyticum Infection; Genital Mycoplasma Infection; HIV Infections Interventions: Other: No intervention Sponsors: University of Bern; Foundation for Professional Development; Utrecht University; University of Pretoria; University of Cape Town; University of Southern California; University of Alabama at Birmingham; Louisiana S...
Source: ClinicalTrials.gov - November 14, 2023 Category: Research Source Type: clinical trials

Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert
Conditions: Safety Issues Interventions: Drug: TAF/EVG vaginal insert; Drug: Matching Placebo vaginal insert Sponsors: Eastern Virginia Medical School; CONRAD; University of Pittsburgh; Centre for the AIDS Programme of Research in South Africa; Kenya Medical Research Institute; United States Agency for International Development (USAID) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 18, 2023 Category: Research Source Type: clinical trials

Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI)
DiscussionThe study findings may facilitate decision-making on (1) whether implementation of the breastfeeding policy achieved the desired outcomes, (2) interventions needed to sustain breastfeeding, and (3) whether the interventions do have an impact on child health.Trial registrationClinicalTrials.gov NCT05063240. Pan African Clinical Trial Registry PACTR202110870407786. Oct. 1, 2021. (Source: Trials)
Source: Trials - October 5, 2023 Category: Research Source Type: clinical trials

Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities
ConclusionCompleting a COVID-19 trial in outpatients during the height of the pandemic required multiple innovations in nearly every aspect of clinical trial management, a high commitment level from study staff and patients, and support from study sponsors. Our experience has generated a more robust clinical research infrastructure, building in efficiencies to clinical trial management beyond the pandemic. (Source: Trials)
Source: Trials - October 4, 2023 Category: Research Source Type: clinical trials

First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF ®10b
Conditions: Healthy Interventions: Biological: H107e; Biological: CAF ®10b; Biological: H107e/CAF®10b - low adjuvant dose; Biological: H107e/CAF®10b - full adjuvant dose; Biological: Low dose intranasal H107e; Biological: Full dose intranasal H107e; Biological: H107e/CAF®10b; Biological: i.m. placebo; Biological: BCG; Biological: i.d. placebo; Biological: Intranas al H107e Sponsors: Statens Serum Institut; Aurum Institute; Bill and Melinda Gates Foundation; Leiden University Medical Center; South African Tuberculosis Vaccine Initiative Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 22, 2023 Category: Research Source Type: clinical trials

Clinical Trial of HIV Vaccine Begins in United States and South Africa
September 20, 2023 -- A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 20, 2023 Category: Pharmaceuticals Source Type: clinical trials

Support for Adolescents Living With HIV in South Africa
Conditions:   Human Immunodeficiency Virus;   HIV Interventions:   Behavioral: In-person adolescent-friendly service (iPAS) intervention;   Behavioral: mHealth (InTSHA) intervention;   Behavioral: Standard of Care Sponsors:   Emory University;   University of KwaZulu;   National Institute of Mental Health (NIMH) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 13, 2023 Category: Research Source Type: clinical trials