Studies

FACES serves as an important platform for novel research. Several studies are underway to improve HIV-related service delivery. Please click any of the links below to jump down to a particular study's details and contact information. To view publications resulting from these and other studies, visit our Publications page. 

UCSF FACES Affiliated Studies

Non-UCSF-Affiliated FACES Studies

 

UCSF-Affiliated FACES Studies

 

SMART-DAPPER - A Sequential Multiple Assignment Randomized Trial (SMART) for Non-Specialist Treatment of Common Mental Disorders in Kenya: Leveraging the Depression and Primary-Care Partnership for Effectiveness-Implementation Research (DAPPER) Project (SMART-DAPPER)

 

Overall aim: The purpose of the SMART-DAPPER study is to identify evidence-based strategies for first-line and second-line (non-remitter) treatment delivered by nonspecialists, including optimal choice of treatment sequences. This study uses a Sequential, Multiple Assignment Randomized Trial (SMART) design to randomize 2,710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD). The study will consist of 12 weekly sessions of nonspecialist-delivered Interpersonal Psychotherapy (IPT) or 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of the first phase of treatment (IPT or fluoxetine) will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). Specific objectives: 

1.    Determine the effectiveness of nonspecialist-delivered IPT, fluoxetine or the combination for MDD and PTSD.

2.    Identify key factors that are associated with successful remission of depression and PTSD from treatment.

3.    Estimate the costs and cost-benefit ratios for fluoxetine and IPT treatment of depression and PTSD.

Study Interventions: Interpersonal Psychotherapy (IPT): This treatment will involve 12-week, diagnosis‐focused psychotherapy to help patients cope with interpersonal crises such as grief, interpersonal conflict or a role transition through building healthy social support and improving communication.The IPT therapists are individuals with a strong interest in providing mental health care and an aptitude for listening and communicating effectively about emotions. The therapists have a wide range of backgrounds including healthcare workers, nutritionists, social workers, HIV testing services (HTS) counselors, anthropologists, teachers, church leaders, women’s group leaders, community leaders and HIV treatment adherence counselors. They have received a classroom-based IPT training course followed by at least four months of supervised practice cases, with ongoing onsite supervision. Fluoxetine: A well-studied antidepressant medication called a selective serotonin reuptake inhibitor (SSRI), fluoxetine is commonly used in public-sector healthcare.Nurses or clinical officers are fluoxetine providers and have been trained on mental disorders and the use of fluoxetine to treat depression and PTSD. They received a classroom-based training course in the use of fluoxetine to treat depression and PTSD followed by at least four months of supervised practice cases, with ongoing onsite supervision.

Study Contact: Rachel Burger

Multiple Principal Investigators: Muthoni Mathai, MB, ChB, MMed (Psych), PhD; Susan Meffert, MD, MPH 

Co-investigators, Consultants & Significant Contributors: Gregory Aarons, PhD, Dickens Akena, MB, ChB, MMed; David Bukusi, MB, ChB, MMed; Craig R. Cohen, MD, MPH; James G. Kahn, MD, MPH; Simon Njuguna, MB, ChB, MMed; Charles McCulloch, PhD; Inbal (Billie) Nahum-Shani, PhD; Thomas Neylan, MD; Linnet Ongeri, ChB, MMed (Psych); Dickens Onyango, MB, ChB; Hafsa Sentongo, MD; Glenn Wagner, PhD.

CCSP acceptability - Cervical cancer prevention among HIV-infected women in Western Kenya: Evaluation of the safety, acceptability, and efficacy of an alternative ablation method for treatment of precancerous lesions

Overall aims: The CCSP study aims to 1. To evaluate the safety, acceptability of Thermocoagulation for treatment of precancerous lesions among HIV-positive women and 2. To evaluate the efficacy of Thermocoagulation for treatment of biopsy confirmed CIN2/3 at 12, 24-months. This study will enroll 400 HIV-positive women at Lumumba Health Center in Kisumu. Intervention: Treatment of precancerous cervical lesions with Thermocoagulation. This study is supported by NIH/Fogarty. Study contact: Chemtai Mungo, MD, MPH Primary Investigators: Chemtai Mungo, MD, MPH, Jackton Omoto MBChB, MMed, Cirillus Ogollah, Megan Huchko, MD, MPH 

 

CCSP acceptability and validation - Feasibility and acceptability of image-based cervical cancer screening and validation of an automated algorithm for cervical screening among HIV-positive women in Western Kenya. 

 

Overall aims: This study aims 1. To evaluate feasibility and acceptability of routine digital photographs of the cervix as part of a cervical cancer screening program in Western Kenya and 2. To train and technically validate an automated computer algorithm for diagnosis of precancer from cervical images among HIV-positive women. This study will enroll 400 HIV-positive women at Lumumba Health Center in Kisumu. Intervention: Digital cervicography with cervical cancer screening. This study is supported by UCSF Global Cancer RAP. Study contact: Chemtai Mungo, MD, MPH Primary Investigators: Chemtai Mungo, MD, MPH, Jackton Omoto MBChB, MMed, Cirillus Ogollah, Megan Huchko, MD, MPH

SEARCH - Sustainable East Africa Research in Community Health

Overall aim: The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the health, economic and educational impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). This first phase will be completed in July 2017. The second phase of the study will quantify the health, economic and educational impact of targeted Pre-Exposure Prophylaxis (PrEP), targeted HIV testing and targeted care interventions in the context of universal treatment and streamlined care. This second phase will be completed in July 2020. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk". Primary endpoint for the first and second phase is HIV incidence measured at 3 years follow-up. Intervention: Phase I: The intervention communities receive annual and targeted HIV testing and ART independent of CD4 cell count delivered in a streamlined approach for all HIV infected adults and children. Components of streamlined care consist of ongoing HIV combination prevention strategies including male circumcision. Control communities will follow country guidelines for ART. Phase II: The intervention communities receive targeted PrEP, targeted HIV testing and targeted care interventions in addition to universal treatment delivered using a streamlined care model. The control communities will receive universal treatment delivered using streamlined care approach. Study contact: Rachel Burger Primary investigator: Craig Cohen, MD, MPH. Status: complete

Mobility - Understanding Mobility and Risk in SEARCH Communities

Overall aim: The study “Understanding Mobility and Risk in SEARCH Communities”, or “Mobility in SEARCH”, for short, addresses an urgent need to better understand how population mobility affects the continued spread of HIV in this region, and how the mobility of HIV-positive people affects their ability to access and stay engaged in HIV care and treatment, through survey gathered data on unique mobility measures and biomarker data on sexual risk. Objectives are:

  1. To measure the mobility of individuals in eastern African communities
  2. To estimate the impact of mobility on HIV incidence
  3. To estimate the impact of mobility on HIV care cascade outcomes

Study contact: Monica Getahun Primary investigator: Carol Camlin, PhD, MPH. Status: Complete 

AdaPT-R - An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care

Overall aim: Assess the comparative effectiveness of sequenced intervention strategies to prevent initial lapses in retention and to treat those that occur. Intervention: Randomize 1,900 adults receiving care at HIV clinics in the Nyanza region of Kenya to (1) standard of care routine education and counseling (REC), (2) SMS text messages, or (3) transport vouchers. Patients with early signs of weakening retention (defined as the first time a patient is 14 days late for an appointment) will be re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with vouchers, or (3) a peer navigator. Patients assigned to SMS or voucher at first randomization who do not experience such a lapse in the first year of follow-up will be randomized to continue or stop their initial intervention assignment. Study contact: Jayne Kulzer Primary investigators: Elvin Geng, MD, MPH and Maya Petersen, MD, PhD. Status: Complete

 

Shamba Maisha

https://shambamaisha.ucsf.edu

  • Agricultural intervention for food security and HIV health outcomes in Kenya (Adult study)
  • An Assessment of the Impact of Nutrition, Health, and Developmental Outcomes of HIV-infected and Affected Children in Western Kenya (Pediatric study)

Overall aims: 

  • Adult: To determine the impact of a multisectoral agricultural and finance intervention on HIV clinical outcomes, and to elucidate the causal pathways (nutritional, mental health, and behavioral) through which the intervention may lead to these outcomes. We also aim to determine whether the intervention is cost-effective and sustainable.
  • Pediatric: The pediatric study will determine the effect of Shamba Maisha on nutritional, health, and neurobehavioral development outcomes of HIV-affected children under 5 years old. Investigators will also work to understand the pathways through which Shamba Maisha may improve nutritional, health, and neurobehavioral development outcomes of HIV-affected children and evaluate the incremental cost and cost-effectiveness of the intervention with respect to children’s health outcomes (in coordination with the adult study’s analysis).

Intervention: The multisectoral intervention includes: a) a loan (~$150) for purchasing agricultural implements and commodities; b) agricultural implements to be purchased with the loan including a human-powered water pump, seeds, fertilizers and pesticides; and c) education in financial management and sustainable farming practices. Study contact: Rachel Burger Primary investigators: Sheri Weiser, MD and Craig Cohen, MD, MPH. Status: Complete  

IeDEA-EA - East African International Epidemiologic Databases to Evaluate AIDS

Overall aim: The East African International Epidemiologic Databases to Evaluate AIDS (IeDEA-EA) is a consortium of partners, including universities from around the world, the World Health Organization and various agencies and private foundations, who have established a number of extensive HIV/AIDS treatment and research networks in the East African nations of Kenya, Uganda and Tanzania. One such entity they have established is a regional data center for East Africa, which not only merges and shares data among current and future partners, but also offers unparalleled research capacity to identify and address questions that are amendable to combined regional database analysis. The long-range goal is to answer the questions that clinicians, programs, and ministries of health consider fundamental to the evolution and sustainability of their long-term HIV care and treatment strategies. FACES’ participation involves retrospective data collection, merging, storage, and data sharing across the East Africa region and disseminating findings through abstracts and publications with the goal of better understanding and promoting HIV services in the region. Intervention: Routine data capture (clinical care data captured in OpenMRS).Study contact: Jayne Kulzer Primary investigator: Constantin Yiannoutsos, PhD and Kara Wools-Kaloustian, MD  

IeDEA-EA Behavioral - East African International Epidemiologic Databases to Evaluate AIDS

Overall aim: The objective of an initial study on alcohol use (cohort studied in 2014) was to gather preliminary data on the prevalence of hazardous alcohol consumption in Kenya and Uganda to assess its impact on patient outcomes. Under this new IeDEA study, investigators follow up on alcohol use among the existing cohort, and add a new behavioral component (alcohol, drugs, and mental health).

Intervention: Within FACES, the initial cohort study, the Alcohol Use Disorders Identification Test (AUDIT-10) was administered at two sites: Lumumba Health Centre in Kisumu and Suba District Hospital in Homa Bay. The objective was to estimate the prevalence of hazardous alcohol consumption in patients enrolling in HIV care and compare their baseline characteristic with non-drinkers and to assess the impact of hazardous drinking on patient outcomes at 6 months. In the new study, all members of the initial alcohol assessment participants will be tracked down to assess the impact of hazardous drinking on patient outcomes after a longer period of time – at 24-36 months follow up. Outcomes include ART adherence, retention in care, and death. We will also assess strategies utilized by patients to address their hazardous alcohol use by conducting a brief semi-structured interview among 25% of the participants at 24-36 moths of follow-up. Investigators will also assemble a Sentinel Behavioral Cohort of adults newly enrolling in care at Lumumba Health Centre and Nyahera Health Centre in Kisumu County. Previously validated surveys on alcohol use, drug use and mental health disorders will be administered. Patient clinic visit adherence will be monitored and patients who miss their visits for 2 or more months will be traced. After at least 12 months of follow-up semi-structured qualitative interviews will be conducted amongst those with any single or combination of alcohol, drug, or mental health disorders. The interview will serve to document all services recommended and or utilized by the patient for treatment of disorders since enrolling in care.

Study contact: Jayne Kulzer Primary investigator: Kara Wools-Kaloustian, MD and Suzanne Goodrich, MD  

FP Validation - Family Planning Implant and Efavirenz Validation Study

Overall aim: Validate electronic medical record findings for the overall implant and efavirenz cohort analysis. Primary investigator and study contact: Rena Patel, MD, MPH. Status: Complete

 

Non-UCSF-Affiliated FACES Studies

Opt4kids - Optimizing viral load suppression in Kenyan children on ART 

Overall aim: Opt4Kids is a randomized, controlled study to pilot the use of point-of-care (POC) viral load (VL) and targeted drug resistance testing (DRT) in children aged 1-14 years on 1stline ART at five sites in Kisumu County with access to GeneXpertÒtechnology. Children are randomized 1:1 to intervention (POC VL and targeted DRT) vs. control (standard-of-care) arms and followed for 12 months. Our primary outcome is the proportion of children achieving VL suppression 12 months after POC VL testing implementation. Study contact: Patrick Oyaro, MBChB, MPH Multiple Principal Investigators: Lisa Abuogi, MD, MS; Rena Patel, MD, MPH Site PI: Patrick Oyaro, MBChB, MPH co-Investigator: Irene Mukui, MBChB, MPH

 

Opt4mamas - Optimizing viral load suppression among pregnant women with HIV in Kenya

Overall aim: This study is evaluating point-of-care (POC) viral load (VL) testing versus routine VL testing in 700 pregnant women newly initiating or already on ART, comparing viral suppression rates pre- and post-intervention implementation.  The intervention entails POC VL testing every three months during pregnancy, at delivery, and at 3 and 6 months postpartum at five facilities in Kisumu County. Our primary outcome is viral suppression rates at the time of delivery and 6 months postpartum between the pre- and post-intervention groups.  Study contact: Patrick Oyaro, MBChB, MPH Principal Investigator: Rena Patel, MD, MPH Site PI: Patrick Oyaro, MBChB, MPH co-Investigators: Lisa Abuogi, MD, MPH and Irene Mukui, MBChB, MPH

 

Jamii Bora - A Home-Based Couples Intervention to Enhance PMTCT and Family Health in Kenya

Overall aim: The objective of this study is to test the efficacy and cost-effectiveness of three different approaches to engaging couples (both HIV-negative and HIV-positive pregnant women and male partners) on health behaviors and outcomes.  Intervention: Trained couple counselors will conduct two home visits during pregnancy, at six weeks after birth, and two booster sessions: at six and 12 months after birth following enrollment of women at an antenatal clinci and subsequent contact with male partner and successful enrollment into the study. At each home visit, the couple counselors will meet with the women and her partner together. All couples are offered Couple HIV Testing and Counseling (CHIC), health pregnancy, infant health, PMTCT/HIV care in concordant positive or discordant relationship messages, male involvement and relationship skills training. The two booster visits will focus on repeat HIV testing, infant health messages, family planning, male health, IPV prevention, mental health, and HIV prevention. Study contact: George Owino, Anna Helova; Site Principal Investigator: Zachary Kwena, PhD; Primary investigator: Janet Turan, PhD, MPH and Lynae A. Darbes, PhD

 

MOTIVATE - Maximizing Adherence and Retention for Women and Infants in the Context of Option B+ in Kenya

Overall aim: The purpose of this research is to address potential barriers that may affect uptake and retention in HIV care for Option B+ in Nyanza, Kenya. Two evidence-based strategies, community-based mentor mothers and mobile phone text messages, are being rigorously tested to examine which strategy—alone or in combination—is more likely to maximize ART adherence and retention in care among HIV-infected pregnant women and HIV-exposed infants in rural Kenya. There is evidence that both of these interventions enhance uptake and retention in PMTCT (Prevention of mother-to-child transmission) and HIV services in sub-Saharan Africa, but they have not been investigated in the context of Option B+. Intervention: 1) HIV-positive community-based mentor mothers with recent PMTCT experience who will support HIV-positive pregnant and postpartum women in their communities/homes; and 2) Individually tailored, theory-based mobile phone text messages to help retain women, and infants in HIV care. Study contact: Iris Wanga, Anna Helova Primary investigators: Lisa Abuogi, MD, MS and Janet Turan, PhD, MPH. Status: Complete

CCCP - Evaluating a Community-Driven Cervical Cancer Prevention Program in Western Kenya

Overall aim: To compare the reach, efficacy and cost-effectiveness of HPV-based testing in a novel community-based cervical cancer screening program with a standard program of HPV-testing in outpatient clinics. Intervention: Phase I: Randomize 3,060 women to receive HPV testing through community health campaigns (intervention communities), and 1,260 women to standard, clinic-based HPV testing (control communities). Phase II: Enroll 2,724 women to community-based HPV testing with enhanced linkage to treatment (enhanced intervention). Study contact: Nelly Yatich, Sandra Oketch Primary investigators: Megan Huchko, MD, MPH and Elizabeth Bukusi, MBChB, MD, MPH, PhD