HIV Infections Clinical Trial
Official title:
HIV Counseling and Testing and Linkage to Care in Uganda
This study will compare the effectiveness of brief versus detailed HIV counseling sessions, paired with referrals to either HIV-specific medical care or usual care, in reducing HIV risk behavior and in increasing treatment adherence in Uganda.
HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that
breaks down the immune system and allows for entry of life-threatening secondary infections.
HIV is a major global health concern, with countries in Africa undergoing a severe HIV/AIDS
crisis. The number of new cases of HIV infection in Africa continues to rise, making disease
prevention methods imperative. Important to the prevention process are early testing,
educational counseling on HIV and how to reduce sexual-risk behavior, and connecting people
with HIV infection to services that offer medical treatment and social support. However, the
most effective strategy for fully integrating HIV counseling, testing, and medical care
access is not known. This study will compare the effectiveness of brief versus detailed HIV
counseling sessions, paired with either referrals to HIV-specific medical care or usual
care, in reducing HIV risk behavior and in increasing treatment adherence in Uganda.
Participation in this study will last 12 months. All participants will undergo an initial
interview to obtain basic information on previous HIV testing and status. Participants will
then be assigned randomly to receive a brief or more detailed counseling session given
before and after HIV testing. Participants assigned to the brief counseling session will
receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and
available services for people infected with HIV. Participants assigned to the detailed
counseling session will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS
information and testing for HIV. After pretest counseling, participants in both groups will
undergo a blood draw for HIV testing. All participants will receive test results and
additional counseling 1 hour after the blood sample is drawn.
Participants who are found to be infected with HIV will be assigned randomly to receive
enhanced referrals to HIV-specific medical care or referrals to usual care. Participants
receiving the enhanced referrals will be provided with more detailed counseling on how to
access HIV services, will be introduced to a specific HIV clinic, and will be given a list
of other HIV services available in the area. After leaving the hospital, participants will
receive reminder telephone calls 1 week before their first scheduled visits at the HIV
clinics. Participants receiving referrals to usual care will be provided with information on
the importance of receiving HIV care and will be given a list of available HIV area
services. At Months 3, 6, 9, and 12, participants in both groups will be interviewed about
contact information, overall health, current medications, sexual history, health services
utilized, and any repeat HIV tests. Participants who are not infected with HIV may be
randomly selected to undergo the same follow-up interviews as the HIV infected participants.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
| Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
| Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
| Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
| Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
| Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
| Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
| Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
| Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
| Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
| Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
| Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
| Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
| Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
| Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
| Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
| Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
| Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
| Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
| Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |