Clinical Research Directory

Case Management Dyad

The overall goal of this study is to test whether dyadic and focused case management coupled with contingency management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.

A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women

African American and Latina women, as well as women living in poverty, are an identified health disparities population for HIV. Risks for HIV are compounded in this population when additional risk factors are present, including other sexually transmitted infections, intimate partner violence, substance use disorders, and homelessness or housing insecurity. Knowledge of one's HIV serostatus is key to linkage to care, improving HIV outcomes, and decreasing the spread of HIV. However, roughly a third of African American women and over half of Latina women have never been tested (CDC, 2016a). Barriers to testing include socioeconomical inequality, racial discrimination, low health literacy, and inadequate access to quality healthcare, among others. Novel methods for increasing HIV testing in this important health disparities group are greatly needed. This study aims to test a reinforcement-based intervention to increase HIV testing and repeat testing among African American, Latina, and women living in poverty who have risk factors for HIV. We are partnering with multiple community-based organizations, several of which are non-traditional providers of HIV services (e.g., domestic violence agency, homeless shelter), to address systemic and structural issues that serve as barriers to testing. A primary aim is to evaluate the effectiveness of training community-based providers to deliver a reinforcement-based intervention for promoting HIV testing. In addition, we will compare standard referral services for HIV testing plus HIV risk reduction education to the same plus reinforcement for HIV testing (and repeat testing) using a randomized controlled trial with 334 participants. Women in both groups will be encouraged to seek HIV testing; be provided with the resources to do so (list of testing sites, bus passes if needed); and will receive basic education about HIV prevention using a widely available web-based resource (https://wwwn.cdc.gov/hivrisk/). Women in the reinforcement group will also be provided with $25 for undergoing an HIV test, with a $15 bonus if they have the test in the next 7 days ($40 total). During the next 12 months, they can receive an additional $25 for undergoing up to 2 more tests separated by 12 weeks, with $15 bonuses for each test completed within 7 days (+/- 7 days) of the scheduled date at 6- and 12-months post-initial test. It is hypothesized that the reinforcement intervention will result in greater proportions of women receiving an HIV test (and repeat HIV tests) compared to standard services. In the proposed study, approximately 50 clinicians from our partner sites will be trained on both the non-reinforcement and reinforcement approaches to increasing HIV testing. Primary clinician outcomes are clinician knowledge and attitudes about HIV, testing, and reinforcement interventions. These will be assessed pre- and post-training and at 6-month intervals thereafter. A secondary outcome is clinician satisfaction with the training. Once clinicians are trained to competence, 334 women at our partner agencies will be randomized. Participants will be assessed at baseline and at 3-, 9-, and 15-month follow-ups. The primary outcome is objective reports of HIV testing, verified by testing centers. Secondary outcomes are HIV risk behaviors, test results, self-efficacy, client attitudes towards testing, and HIV knowledge. In addition, this study will include a careful analysis of costs of the reinforcement intervention to allow for estimates of its cost-effectiveness in increasing HIV testing. The overall goal of this study is to determine whether a reinforcement intervention delivered by community providers is superior to standard referral procedures plus HIV education in increasing rates of HIV testing among women at the highest risk of HIV infection. A wide range of community partners that serve some of the highest risk groups of women were chosen to ensure highly generalizable results. If efficacious, the intervention has the potential for widespread adoption and implementation.

Implementing a Contingency Management Program Addressing Methamphetamine Use for and With the People of Hawai'i

This clinical trial is to implement contingency management (CM) as an intervention tool to address methamphetamine use and will be initiated during inpatient acute hospitalization in trauma injured patients. The goals are: * Gather effectiveness data on a CM program for participants in Hawaii who use methamphetamine during hospitalization and following discharge due to trauma injury * To assess participant perspectives on engaging with a CM program based at a Level 1 Trauma Center. Researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program. * To assess the rate of leaving against medical advice (AMA) and treatment completion in acute hospital setting in participants. * To assess the optimal timing of CM initiation for traumatically injured hospitalized patients by comparing patient outcomes (i.e. duration of CM participation and rates of CM program completion and providing negative urine samples) to NCT06532370 where CM was initiated after discharge from the hospital. For total of 12 weeks, participants will: * Be visited on Mondays/Thursdays or Tuesdays/Fridays by the research team to complete urine analysis during the hospitalization * Visit a follow up clinic up to 2 times per week on Mondays/Thursdays or Tuesdays/Fridays to complete urinalysis following discharge from the hospital * Complete Treatment Effectiveness Assessments at 6 and 12 weeks * Engage in qualitative interview at the end of the CM program

Substance Use in Pregnancy - Optimizing Retention in Treatment

Substance use during pregnancy is a leading cause of maternal morbidity and mortality in the United States, with 55-80% of postpartum patients disengaging from substance use disorder (SUD) treatment within one year of delivery. Structural and social determinants of health, including housing instability, transportation barriers, and limited childcare access, further exacerbate disparities in treatment retention. This pilot study, conducted in two specialized prenatal care clinics, evaluates the feasibility and acceptability of two integrated strategies to promote sustained engagement in recovery-oriented services during the perinatal and postpartum periods. Aim 1 implements a standardized social needs screening and referral protocol to connect patients with community-based supports. Aim 2 pilots a contingency management intervention to incentivize recovery-supportive behaviors. Findings will inform the design of a larger multi-site randomized controlled trial to evaluate the impact of these interventions on treatment retention, overdose prevention, and maternal-infant health outcomes.

Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms

This study aims to learn about depression and alcohol use in postpartum mothers and whether an intervention based on contingency management and problem-solving therapy (CM-PST) can help reduce these symptoms. The main questions it seeks to answer are: 1. How do new mothers fare with depressive symptoms and alcohol use in the first 12 months after giving birth? 2. Will a CM-PST intervention reduce depressive symptoms and alcohol use frequency among new mothers? 3. Is a CM-PST intervention practical for new mothers? The researchers will recruit approximately 30 new mothers and randomly select half to attend a 6-week CM-PST intervention. They will compare those who received the intervention versus those who did not to see if there are any differences in their depressive symptoms and alcohol usage. Participants will: * Complete 4 remote intervention sessions over 6 weeks * Conduct at-home urine drug tests 2x per week during the 6-week intervention * Answer online surveys about their mental health and alcohol use

J-RISE: Relevant Implementation Strategies to Eliminate the Social and Structural Barriers to HIV Services Among Justice-involved Black Men Who Have Sex With Men and Other Key Populations

The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system. The main question it aims to answer is: • Compared with the Health Navigation group, are participants in the Health Navigation Plus group more likely to a) access HIV care, treatment, and prevention services and employment services and b) access employment services and be employed in community? Participants on the study will be: * Randomly assigned (like a flip of a coin) to participate in either Health Navigation or Health Navigation Plus. Participants will have an equal chance of being placed in either group. * Complete three surveys over the course of 13 months * Participants in the Health Navigation group will have two in person meetings and seven check-ins with the health navigator over 6 months * Participants in the Health Navigation Plus group will have two in person meetings and seven check-ins with the health navigator over 6 months, two in person and 10 check ins with the employment navigator over 12 months and up to $200 to support employment and career development needs and receive up to $140 to support health goals. Samples of blood, urine and swabs may be collected to meet the health goals.

CM for Patients With ALD After Liver Transplant

Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use. The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom or by phone. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility.

Persistent Poverty Counties Pregnant Women With Medicaid

Although many women initially quit smoking during pregnancy, most will return to smoking by the end of pregnancy or during the first 6 months postpartum. The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation coaching and biochemically-verified smoking abstinence at follow-up among pregnant women with Medicaid insurance who contact the Oklahoma Tobacco Helpline (OTH). The study will enroll 100 pregnant women who will be randomly assigned to OTH care or OTH plus escalating incentives (OTH+I) for completing up to 5 coaching calls over the first 8 weeks after enrolling (prepartum) and for biochemically-verified smoking abstinence at 9 weeks post-enrollment (assessed remotely via smartphone). In addition, participants will be incentivized for completing a postpartum coaching call by 8 weeks postpartum. Feasibility outcomes for the incentives based intervention will focus on coaching call completion, rates of prepartum and postpartum follow-up, biochemically-verified smoking cessation, and perceptions of the intervention. Potential effectiveness will be evaluated by comparing biochemically-verified smoking abstinence rates in OTH+I relative to OTH alone at 12 weeks post-enrollment (prepartum) and 12 weeks postpartum.