ABOUT RESOLVE

Summary of the RESOLVE Research Study

The RESOLVE study is a clinical trial aimed at improving the management of virologic failure in individuals living with HIV who are on a specific antiretroviral therapy (ART) regimen called TLD (a combination of tenofovir, lamivudine, and dolutegravir). The study will be conducted in Uganda and South Africa, where HIV is highly prevalent, and will evaluate three different strategies to determine the most effective and cost-efficient approach to help people achieve viral suppression.

Study Goals:

1. Aim 1: Conduct a randomized clinical trial to compare three strategies for managing virologic failure on TLD:

   • Standard of Care: Current national guidelines in Uganda and South Africa.
   • Individualized Care: Treatment tailored to the individual using genotypic resistance tests, urine tenofovir adherence tests, and patient preferences.
   • Immediate Switch: Immediate switch to a protease inhibitor (PI)-based second-line ART regimen. The primary goal is to determine which strategy leads to the highest rate of viral suppression (HIV-1 RNA viral load <50 copies/mL) at 48 weeks.

2. Aim 2: Use simulation modeling to assess the long-term clinical impact, costs, and cost-effectiveness of the three strategies.

Eligibility Criteria: To participate in the study, you must meet the following criteria:

• Inclusion Criteria:

  1. Be 15 years of age or older.
  2. Be enrolled in HIV care at one of the study clinics in Uganda or South Africa.
  3. Have a history of two consecutive HIV-1 RNA viral load measurements >1,000 copies/mL while on TLD. The first viral load must be drawn at least five months after starting TLD, and the two measurements must be at least two months apart.
  4. Have been on TLD for at least 12 months (including those who switched from other regimens or experienced virologic failure on a previous regimen).
  5. Live within 100 kilometers of the study clinic to ensure follow-up.

• Exclusion Criteria:

  1. Plans to transfer out of the clinic within the next 48 weeks.
  2. Plans to move out of the study area within the next 48 weeks.
  3. Known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.

What to Expect:

• Participants will be randomly assigned to one of the three study arms (Standard of Care, Individualized Care, or Immediate Switch).
• Study visits will occur at Week 0, Week 24, and Week 48, with additional visits as needed.
• Participants will undergo tests such as viral load measurements, genotypic resistance testing, and adherence assessments.
• Pregnant women and adolescents aged 15-18 years are eligible, with special protocols in place to ensure their safety and privacy.
• Participants will receive transportation reimbursement and small incentives for their time.

Benefits: Participants may benefit from additional tests and personalized care provided by trained clinicians. The study aims to improve the understanding of the best ways to manage virologic failure on TLD, which could help millions of people living with HIV in sub-Saharan Africa.

Privacy and Confidentiality: All study procedures will be conducted in private settings, and personal information will be kept confidential. Data will be securely stored and shared only with authorized research team members.

How to Participate: If you meet the eligibility criteria and are interested in participating, you can learn more by speaking with the Adrenergy study staff at RK Khan ARV Clinic.  Participation is voluntary, and your decision will not affect your clinical care.