Research in Behavioral Medicine
International Research Projects
Patient-Oriented Substance Use/Smoking Cessation Research in HIV Treatment and Prevention
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: National Institute on Drug Abuse (NIDA)
Project Number: 1K24DA062568-01
Description: First, we will utilize original data from HIV primary care clinics in Cape Town, SA to examine the impact of substance use on engagement in HIV care. Second, we propose an examination of the longitudinal relationships between smoking status variables and HIV clinical and treatment outcomes will be conducted in the CNICS cohort. Third we will undertake a qualitative study to identify barriers and facilitators to implementation of smoking cessation in HIV care settings. Finally, we will conduct a moderation analysis of our NIDA R01 smoking cessation trial of the treatment effects associated with virtual intervention delivery.
Potential Participants: Not yet recruiting.
TENDAI4PrEP: Adaptation of a Problem-Solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Persons in Zimbabwe
Principal Investigators: Conall O’Cleirigh, PhD, Walter Mangezi, MBChB, MMed, and Amelia M. Stanton, PhD
Funding Source: National Institute of Mental Health (NIMH)
Project Number: 1R34MH134698-01A1
Description: This study aims to prevent HIV acquisition and transmission among pregnant and postpartum women in Zimbabwe. This study extends the previous TENDAI study into a multi-level, problem-solving PrEP use intervention (TENDAI4PrEP) for pregnant persons with psychological distress, their partners, and antenatal care providers. TENDAI4PrEP supports PrEP adherence and persistence during pregnancy among individuals with psychological distress who have agreed to initiate PrEP use. In Aim 1, researchers explore the impact of intersecting, multi-level barriers to PrEP uptake, adherence, and persistence among pregnant persons as well as barriers to the provision of PrEP among antenatal care providers. In Aim 2, researchers use the formative data to specify the intervention, likely involving a patient component (inclusive of a dyadic session with a partner) and a provider component, and conduct a small proof-of-concept trial. In Aim 3, researchers evaluate the feasibility and acceptability (primary outcomes) of (a) the patient-level intervention in a pilot RCT and (b) the provider-level component in a pre-post design.
Potential Participants: Currently open to enrollment for participants in Chitungwiza.
Treatment Development for Smoking Cessation and Engagement in HIV/TB Care in South Africa
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: National Institute of Health (NIH) / National Institute on Drug Abuse (NIDA)
Project Number: 5R34DA057169-02
Description: This study develops QUIT-AD, a novel intervention that integrates the QUIT program for smoking cessation with cognitive behavioral strategies that have been culturally adapted to improve treatment adherence among people with HIV (PWH) and/or TB in South Africa. This research facilitates a more thorough understanding of (a) barriers to smoking cessation among adults with HIV and/or TB and (b) barriers to TB treatment adherence among adults with TB who use tobacco (Aim 1); adapts the QUIT protocol, adding and removing content based on the formative data, and conducts a small proof-of-concept open trial (n = 5; Aim 2); and assesses feasibility and acceptability of the intervention in a pilot RCT to be task shifted to lay counselors (Aim 3).
TENDAI Study: Task Shifting to Treat Depression & HIV Medication Nonadherence
Principal Investigators: Conall O’Cleirigh, PhD, Melanie Abas, MD, and Walter Mangezi, MBChB, MMed
Funding Source: National Institute of Health (NIH)
Project Number: R01MH114708
Description: Zimbabwe has the 5th highest prevalence of HIV globally, and depression has been identified as a major hurdle to people living with HIV (PLWH) adhering to their antiretroviral medication in this setting. Unfortunately, due to the dearth of mental health professionals in sub-Saharan Africa, there is a significant depression treatment gap. This project is a two-arm randomized effectiveness trial (n=290) evaluating the effectiveness and cost-effectiveness of a brief, stepped-care intervention for depression and ART adherence (TENDAI), in compared with an enhanced standard care condition, in patients living with HIV in rural Zimbabwe. To counter the mental health treatment gap, this study prioritizes task-shifting using adherence counselors and nurses as interventionists, and the stepped-care approach utilizes three successive intensity levels of depression treatment for non-responders to maximize efficient use of resources in resource limited settings. Outcomes for the project include viral suppression, medication adherence, and depression.
Potential Participants: No longer recruiting.
Ukubandakanya abesilisisa: HIV Self-Testing for Partners of HIV-Uninfected Postpartum Women to Facilitate PrEP and ART Uptake to Promote HIV Treatment and Prevention
Principal Investigators: Christina Psaros, PhD and Lynn T. Matthews, MD, MPH
Funding Source: National Institutes of Health (NIH)
Project Number: 1R34MH132446-01A1
Description: This project aims to enroll 60 women who test negative for HIV at the end of pregnancy and have an HIV-negative or serostatus-unknown partner, and distribute HIV self-testing kits for male partners, in order to evaluate acceptance, uptake, and self-reported use of HIV self-testing kits, as well as facilitators and barriers to distribution of HIV self-testing kits to partners. We will also evaluate male partners’ uptake of HIV self-testing kits and linkage to HIV care as applicable.
Potential participants: Not yet recruiting.
Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
Principal Investigator: Christina Psaros, PhD
Funding Source: National Institute of Mental Health (NIMH)
Project Number: 1R34MH126753-01A1
Description: This project aims to collect formative, qualitative data to inform the adaptation of an established stress management and resiliency enhancing intervention (the Relaxation Response Resiliency Program; 3RP) for delivery to nurses providing HIV care in the public sector in South Africa.
Potential participants: Currently recruiting nurses working in the public sector in South Africa.
Potential Participants: Not yet recruiting.
Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade among Women with HIV in South Africa: Part 2
Principal Investigator: Christina Psaros, PhD
Funding Source: National Institute of Health (NIH)
Project Number: 1R21CA279942-01
Description: The purpose of this study is to develop and test the feasibility and acceptability of a patient-level intervention and provider toolkit to increase retention in care among women with HIV (WWH) who received high-risk abnormal Pap Smear results.
Potential Participants: Not yet recruiting.
PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women
Principal Investigator: Lynn Matthews, MD, MPH
Co-Investigator: Christina Psaros, PhD
Funding Source: National Institute of Mental Health
Project Number: R01 MH10842
Description: This is a single-arm study to offer daily oral PrEP for periconception use, in conjunction with safer conception counseling, to 350 HIV-uninfected women in KwaZulu-Natal, South Africa who report personal or partner plans for pregnancy and a partner who is HIV-infected or HIV-status unknown.
Potential participants: No longer recruiting.
Identifying and Exploring Impacts and Interrelationships of Syndemic Problems on HIV Outcomes in South Africa
Principal Investigator: Jasper Lee, PhD
Funding Source: Harvard University Center for AIDS Research
Project Number: 5P30AI060354-17 Developmental Award
Description: The purpose of this study is to investigate the effects of clinically significant syndemic problems (i.e., food insecurity, depression, substance use disorder, and post-traumatic stress disorder [PTSD]) on antiretroviral therapy adherence (via pharmacy refill and self-report) and HIV RNA viral load among people with HIV (PWH; N=120) in South Africa. It is also to conduct qualitative interviews to examine the complex interrelationships of syndemic problems and attitudes toward potential future intervention components, as well interviews among nurses (n=10) and other clinic providers/administrators (n=8) at primary care clinics where HIV services are provided in Khayelitsha or Langa to assess the perceived feasibility of a cognitive-behavioral therapy (CBT) intervention for syndemic problems and adherence.
Potential Participants: Currently open to enrollment to participants in South Africa.
Developing and Piloting a Multilevel Intervention to Address Psychosocial and Structural Syndemics in People with HIV in South Africa
Principal Investigator: Jasper Lee, PhD
Funding Source: National Institute of Mental Health
Project Number: 1K23MH135748-01
Description: In South Africa, the country with the highest HIV prevalence (19%), comorbid problems such as depression, post-traumatic stress, and food insecurity synergistically enhance one another (i.e., syndemic problems) and are associated with worse HIV outcomes such as poorer antiretroviral therapy (ART) adherence and worse viral load. This study proposes to: 1) explore the complex interrelationships between syndemic problems and explore attitudes to potential intervention components; 2) develop a multilevel intervention to address syndemic problems and improve adherence (CBT-SA); 3a) assess the feasibility and acceptability of CBT-SA in a pilot RCT; and 3b) identify barriers and facilitators of CBT-SA engagement. If the CBT-SA intervention is found to be feasible and acceptable, and findings suggest clinically meaningful improvement, the multilevel CBT-SA intervention could be further examined for effectiveness, which could advance the field toward the ending the HIV epidemic initiative.
Potential Participants: Currently open to enrollment for participants in South Africa.
Mental Health Barriers to PrEP Uptake among Pregnant Women in South Africa
Principal Investigator: Amelia M. Stanton, PhD
Funding Source: Harvard Center for AIDS Research NIH/NIAID 5P30AI060354-17
Description: South Africa (SA) has the largest population of individuals living with HIV in the world. Women of reproductive age in SA are at disproportionately high risk for acquiring HIV compared to their male counterparts. Potential reasons for this discrepancy include gender-based violence, lack of agency in the context of intimate partnerships, sex with older men who are more likely to be infected, and low condom use rates. Pregnant women face particularly high HIV risk, as pregnancy and breastfeeding are associated with increased biological susceptibility to HIV infection. Adherence to once daily oral tenofovir-based PrEP is efficacious in preventing HIV acquisition, but PrEP uptake, adherence, and persistence in SA and has been poor. Pregnant women in SA are interested in taking PrEP, but they face numerous challenges, including psychological issues associated with intimate partner violence, traumatic stress, and depression, which may compromise engagement in HIV prevention behaviors. The main objective of this study is to collect mixed-methods data to inform a future cognitive behavioral therapy intervention that facilitates PrEP persistence by addressing relevant psychological barriers among HIV-negative pregnant and postpartum women.
Potential participants: Currently open to enrollment for participants in South Africa.
Falling off the HIV Treatment Cascade Cliff: Understanding Postpartum Attrition to HIV Care
Principal Investigator: Christina Psaros, PhD
Funding Source: National Institute of Mental Health (NIMH)
Project Number: R01 MH112385
Description: The province of KwaZulu-Natal, South Africa, has the highest prevalence of HIV among pregnant women in the world: 40% of women enrolled in antenatal care are living with HIV. Pregnancy is an important time to engage women in HIV care to eliminate perinatal transmission through prevention of mother to child transmission programming (PMTCT), but it also presents an opportunity to engage women in lifelong HIV care. Many women leave HIV care during the postpartum period, even though ongoing care is imperative to maintaining their health and the health of their infants. The research community does not know enough about why women leave HIV care during the postpartum period, thus we cannot yet design interventions to retain more women in HIV care. The goal of this study is to better understand barriers to and facilitators of remaining in HIV care after having a baby in the province of KwaZulu-Natal, South Africa, with the ultimate goal of developing interventions to best support the health of women living with HIV and their children.
Nurse-Delivered CBT for Depression-Adherence in HIV Primary Care in South Africa
Principal Investigators: Conall O’Cleirigh, PhD and Steven Safren, PhD, ABPP
Funding Source: National Institute of Health (NIH)
Project Number: R01 MH103770
Description: This study involved a two-arm randomized effectiveness trial investigating whether a task shifting/sharing model of treating depression and improving adherence to ART in patients who fail first line antiretroviral therapy (ART) can occur using nurses in South Africa trained in CBT. South Africa is the country with the highest number of HIV infections in the world and the highest number of HIV/AIDS-related deaths, and where access to third line ART treatment is not currently available in the public healthcare system. Clinical depression, like elsewhere, is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. The U.S. based investigators have developed and successfully tested an approach integrating adherence counseling into cognitive- behavioral therapy for depression in HIV. The South Africa based team, in collaboration with the U.S. based team, has conducted preliminary work to evaluate the cultural appropriateness and feasibility of integrating this approach into the South African HIV treatment setting.
Accordingly, we have:
- Conducted an open-pilot of the treatment in Cape Town with 6 HIV-infected patients with depression using a clinical psychology PhD student as the therapist
- Conducted formative qualitative research on the manifestation of depression and ways to adapt this approach for the South Africa HIV care setting
- Successfully trained two clinic nurses in the adapted version of the intervention Completed an open pilot feasibility trial with 14 patients with these nurses as interventionists
Preventing Weight Gain and Diabetes in People with HIV in South Africa
Contact Principal Investigator: Jennifer Manne-Goehler, MD, ScD
Collaborators from BMED: Christina Psaros, PhD
Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases
Grant Number: 5K23DK125162-05
Description: Dolutegravir (DTG)-based antiretroviral therapy (ART) has recently been adopted as the first-line regimen in most of sub-Saharan Africa, despite evidence that it is associated with excess weight gain. While the HIV care system offers a capable health systems platform, obesity and diabetes prevention are not a current focus of care paradigms. Through this study, researchers explore the metabolic effects of DTG among people with HIV (PWH) in South Africa and develop and pilot an intervention to mitigate these complications. The specific aims of this study are: 1) To determine the behavioral correlates of weight change and glucose intolerance for PWH transitioning to DTG-based ART in South Africa; 2) To develop an acceptable and contextually appropriate intervention to prevent weight gain and diabetes in PWH on DTG-based ART in South Africa; and 3) To conduct a factorial-randomized feasibility study of interventions to prevent weight gain and diabetes among PWH on DTG-based ART versus usual care.
Development and Assessment of an HIV Disclosure Intervention for Men in Uganda
Contact Principal Investigator: Pooja Rao Chitneni, MD
Collaborators from BMED: Christina Psaros, PhD
Funding Source: National Institute of Mental Health (NIMH)
Grant Number: 5K23MH126771-02
Description: The goal of this study is to develop and test an HIV disclosure intervention focused on men with HIV (MWH) in Uganda meeting the following eligibility criteria: with STI symptoms who are either not accessing antiretroviral therapy or are accessing antiretroviral therapy but without viral suppression. In Aim 1, researchers identify the unique HIV disclosure needs and preferences to support HIV disclosure through in-depth qualitative interviews with up to 30 MWH meeting eligibility criteria. In Aim 2, researchers utilize the findings from Aim 1 to adapt interventions with HIV disclosure components to develop a novel HIV disclosure intervention focused on MWH. The intervention is refined through focus group discussions with up to 20 participants, their sexual partners, and a community advisory board. In Aim 3, researchers recruit 70 MWH meeting eligibility criteria for participation in a randomized controlled trial to pilot test the intervention against an attention-matched control group. Participants are encouraged to bring their sexual partners for study enrollment and HIV testing and counseling. Up to 15 MWH and their sexual partners are invited for qualitative interviews.
Reducing Psychological Barriers to PrEP Persistence among Pregnant and Postpartum Women in Cape Town, South Africa
Contact Principal Investigator: Amelia M. Stanton, PhD
Collaborators from BMED: Conall O’Cleirigh, PhD and Christina Psaros, PhD
Funding Source:
Grant Number: 5K23MH131438-02
Description: The overarching goal of this study is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition in South Africa.
The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop and conduct a proof-of-concept test of a brief PrEP adherence and persistence intervention that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility and acceptability of the intervention, which is integrated into antenatal care, in a pilot randomized controlled trial.
INTSHA: Interactive Transition Support for HIV-Infected Adolescents Using Social Media
Contact PI: Brian C. Zanoni, MD
Collaborators from BMED: Christina Psaros, PhD
Funding Source: National Institute of Mental Health (NIMH)
Grant Number: 5K23MH114771-04
Description: This study iteratively develops a social media behavioral intervention using the SMART model (knowledge, self-efficacy, beliefs, maturity, goals, relationships, peer and social support) for adolescents living with HIV and transitioning to adult care in South Africa. This novel study is designed to address transition outcomes (i.e., retention in care and viral suppression) for HIV-infected adolescents in sub-Saharan Africa where 90% of the pediatric HIV-infections exist. Data is collected through in-depth qualitative interviews to determine how social media can overcome barriers and enhance facilitators of successful transition to adult care for adolescents living with HIV in South Africa (Aim 1). Researchers iteratively adapt the social media based behavioral intervention, Interactive Transition Support for HIV-infected Adolescents (InTSHA; meaning youth in Zulu), using focus groups with adolescents, their caregivers, and healthcare providers (Aim 2). Finally, a pilot clinical trial of the intervention (Aim 3) determines the intervention’s acceptability and feasibility.
Screening Strategies for Sexually Transmitted Infections in a High HIV Incidence Setting in South Africa
Contact PI: Jana Jarolimova, MD
Collaborators from BMED: Christina Psaros, PhD
Funding Source: National Institute of Allergy and Infectious Diseases
Grant Number: 1K23AI174917-01A1
Description: This study applies new methods to the design and evaluation of STI screening strategies in rural South Africa. This study assesses young people’s preferences for STI screening and design and evaluates a community- based STI screening strategy in rural South Africa. This study consists of the following specific aims: 1) To evaluate motivation and preferences for STI screening among adolescents and young adults using qualitative methods, 2) To conduct a Discrete Choice Experiment to quantify young people’s preferences for community-based STI screening, and 3) To evaluate the implementation of a new community-based STI screening strategy among adolescents and young adults.
