Research

Research Areas: Kisumu, Homa Bay and Migori Counties


Click any of the links below to jump down to a particular study’s details and contact information. This information was last updated in February 2017.

UCSF FACES Affiliated Studies

Non-UCSF-Affiliated FACES Studies

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

 

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

 

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 2,500 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

 

Shamba Maisha: 

      • 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

 

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

 

TextIT – Texting to Improve Testing

Overall aim: Our overall objective is to improve the continuum of care within PMTCT (Prevention of mother-to-child transmission) programs by promoting patient retention and enhancing follow-up care for mother-baby pairs.

Intervention: This study involves 2508 participants randomized to 10 control and 10 intervention sites. In the intervention sites, eligible participants receive text messages based on their gestation. The participants receive a total of 54 messages till 9 months postpartum. They may also send back messages or call 24/7 where an online nurse responds.

Study contact: Harriet Fridah Adhiambo
Primary investigators: Elizabeth Bukusi, MBChB, MD, MPH, PhD

 

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

 

ART-C – Impact of earlier antiretroviral treatment implementation on use of more effective contraception, pregnancy incidence, and fertility desires among HIV positive women in Kenya

Overall aim: Evaluate the impact of earlier ART on fertility desires, contraceptive use, and pregnancy incidence in HIV-positive women.

This study involves three layers of data collection. The first layer is through data collected from electronic medical records from OpenMRS, 12 months pre- and post- ART policy changes (July 2014 implementation of earlier ART, i.e. ART initiation at CD4 counts up to 500, and July 2016 implementation of universal ART, i.e. ART regardless of CD4 counts). The second layer involves facility-level interviews with providers and the third layer consists of in-depth interviews with female participants.

Primary investigator and study contact: Rena Patel, MD, MPH

 

DTAS – The feasibility and the impact of designated time appointment system at FACES-supported clinics in Nyanza, Kenya

Overall aim: To test a designated time appointment system in HIV care clinics to establish if it is feasible in terms of patients keeping time, as well as measure its impact on time spent at the care clinics and consequently on the patients’ productivity, adherence to clinic visits, service satisfaction and health outcomes.

Intervention: Patients are given a specific date and time to arrive for their clinic visits.

Study contact: Catherine Makokha
Primary investigator: Zachary Kwena, PhD, MA

 

The Kanyakla Study: A Social Network Intervention for Promoting Engagement and Retention in HIV Care (Adult)

Overall aim: The objective of this study is to evaluate a social network intervention designed to improve engagement and retention in clinical care for HIV-infected individuals at high risk of disengagement from medical care on Mfangano, Remba and Ringiti Islands, Western Kenya.

Intervention: All FACES patients at participating clinics on Mfangano, Remba, Takiwiri, and Ringiti islands who miss a clinical appointment by >30 days were invited to participate. These patients were either randomized into intervention or control arms. The intervention group started a community-based education program designed to train high-risk patients on ART along with self-identified social support networks on how to manage long-term HIV care. Subjects and their self-chosen support networks formed “microclinics” or “Kanyaklas” and underwent 8 training sessions led by local CHWs and OHR staff with a focus on confidentiality, adherence and disclosure. Following 12 months of follow-up, all control group patients will be provided with the same education program.

Study contact: Dan Omollo
Primary investigators: Matt Hickey, MD; Chas Salmen, MD, MPhil; and Katie Fiorella, PhD MPH

 

The Kanyakla Study: A Novel Social Support Approach to Optimize Healthcare Amongst HIV Infected Adolescents (Adolescent)

Overall aim: Assess the effectiveness of a social networking intervention to improve retention amongst adolescents living with HIV.

Intervention: 65 HIV infected index participants (15-19 yr) on ART from 2 study sites in the same county will be enrolled and asked to recruit 2 social network participants to participate in a biweekly therapy collective (kanyakla) over a 3-month period.

Study contact: Dan Omollo
Primary investigator: Hilary Wolf, MD

 

eMCHR – Electronic Maternal Child Health Record

Overall aim: Determine the effectiveness and feasibility of an electronic Maternal Child Health Record (eMCHR) with regard to uptake of maternal, newborn, and child healthcare (MNCH) services and retention.

Intervention: A cluster randomized stepped wedge study design will be used to compare mother-baby pair retention, and service uptake along the MNCH cascade at 12 health facilities in Homa Bay County implementing a combination of eMCHR and an intervention combining (1) 4 key registers into a longitudinal electronic maternal child health record with (2) text message reminders and on-screen prompts for health care providers and (3) a call center manned by mentor mothers for following up mothers. Twelve health facilities in Homa Bay County will be randomized to intervention or control. The six facilities randomized to intervention will implement eMCHR in the first step while the remaining six control facilities will continue with routine paper-based records. In the second step, the six control facilities will also receive the intervention. We will compare uptake of four ANC visits, skilled deliveries, postpartum family planning, and documentation among study sites.

Study contact: Violet Nasenya
Primary investigators: Edwin Mulwa, Eliud Akama

 

M-Access – Evaluating the Use of Mobile Phone Technology in Maximizing Access and Utilization of Maternal and Newborn Health Services in Homa Bay County

Overall aim: To evaluate the impact of utilizing mobile phone technology in improving access and utilization of maternal and neonatal health services.

Intervention: A mobile phone based tool that offers: an SMS based registration system and loyalty program to encourage use, 24 hr transport navigation system, and personalized trimester based text messages.

Study contact: Titus Serem
Primary investigator: Maricianah Onono, MD

 

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

Overall aim: The purpose of this study is to develop and pilot-test a home-based intervention that reaches both HIV-negative and HIV-positive pregnant women and male partners to facilitate safe HIV testing and disclosure within pregnant couples in order to increase use of prevention-of-mother-to-child-transmission (PMTCT) and family health services in the Nyanza region of Kenya.

Intervention: Trained couple counselors will conduct two home visits during pregnancy and one home visit postpartum to couples randomized into the intervention study arm. Home visits are conducted with the couple alone in a private room in the household, or at a nearby location in the community. All couples are offered Couple HIV Testing and Counseling (CHTC) and healthy pregnancy, birth, and postnatal messaging, and additional content related to PMTCT and HIV care is provided to couples in which one or both partners are HIV-positive.

Study contact: George Owino, Anna Helova
Primary investigator: Janet Turan, PhD, MPH

 

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

 

ECHO – The Evidence for Contraceptive options and HIV Outcomes Trial

Overall aim: A multi-center, open-label, randomized clinical trial comparing the risks of HIV acquisition between women randomized to Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs).

Intervention: Approximately 1,000 HIV antibody negative women aged 16-35 years will be enrolled at our site and randomized in a 1:1:1 ratio to DMPA, LNG implant or the copper IUD and followed for 18 months of contraceptive method use. The study size and follow-up is expected to yield at least 250 HIV endpoints for each of the three method comparisons: copper IUD vs. DMPA, LNG implant vs. DMPA, copper IUD vs. LNG implant, yielding 80% power to detect 50% increases (equivalently, 33% reductions) in the risk of HIV between any two methods. Enrollment is expected to take approximately 18 months for each woman, and the total duration of the study in the field will be approximately 36 months from first enrollment.

Study contact: Imeldah Wakhungu
Primary investigators: Elizabeth Bukusi,, MBChB, MD, MPH, PhD and Maricianah Onono, MD

 

Community FP – Investigating a Masculinities-Based Approach to Increase Male Acceptance of Family Planning in Kenya

Overall aim: Evaluate the effectiveness of an intervention focused on male gender norms to increase male acceptance of family planning.

Intervention: Male study participants selected from the intervention community will 1) participate in three small-group workshops focused on male gender norms and family planning, and 2) have the option to attend community presentations about male involvement in family planning being held in their community during the six-month intervention period. Male study participants selected from the control community will only participate in data collection.

Study contact: Jennifer Zakaras
Primary investigators: Sara Newmann, MD, MPH and Shari Dworkin, PhD, MS