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FACES Research Studies

This research list was last updated in May 2015. To download this summary as a PDF, click here.

Shamba Maisha

Despite major advances in care and treatment for those living with HIV, morbidity and mortality among people living with HIV/AIDS (PLHIV) remain unacceptably high in sub-Saharan Africa (SSA), largely due to the parallel challenges of poverty and food insecurity. Yet, to date there have been few studies to systematically evaluate the impact and cost-effectiveness of promising food security interventions on health outcomes among PLHIV. To address these gaps, together with KickStart, a non-governmental organization based in SSA, we have developed a multisectoral intervention in Nyanza Region, Kenya that includes: a) a microfinance loan (~$175) 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. We successfully completed an NIH-funded pilot intervention trial that showed that the intervention was feasible, acceptable and may improve HIV-related health. We now plan to conduct a cluster randomized controlled trial (RCT) of this intervention with the following specific aims: to determine the impact of a multisectoral agricultural intervention among HIV-infected farmers on ART on HIV clinical outcomes; to understand the pathways through which the multisectoral intervention may improve HIV health outcomes; and to determine the cost-effectiveness of the intervention and obtain the information necessary to inform scale-up. To accomplish the first two aims we will randomize 8 matched pairs of health facilities in the Nyanza Region in a 1:1 ratio to the intervention and control arms, and enroll 44 participants per facility (total n=704). All participants will be followed for 2 years. To accomplish the third aim, we will: a) conduct a cost-effectiveness analysis; b) identify the characteristics of individuals most likely to benefit from the intervention and c) perform a mixed-methods process evaluation to guide future scale-up efforts of the intervention. Our ultimate goal is to develop and test an intervention to reverse the cycle of food insecurity and HIV/AIDS morbidity and mortality in SSA.

Contact: Sheri Weiser,

Craig Cohen,

Prevalence and Impact of Alcohol Use in Patients Enrolling in HIV Care (PIAUPEHC, “Alcohol & HIV Study”), an East African International Epidemiologic Databases to Evaluate AIDS (IeDEA-EA) Project

The objective of this study is to gather preliminary data on the prevalence of hazardous Alcohol consumption in our population and to assess its impact on patient outcomes. The Specific Aims are to: estimate the prevalence of hazardous alcohol consumption in patients enrolling in HIV- care and compare their baseline characteristic with those of non-drinkers and assess the impact of hazardous drinking on patient outcomes including time to antiretroviral therapy (ART) initiation, medication adherence, retention in care, and death.The study started enrollment on 17 Feb 2014 and concluded enrollment on 30th May 2014 and patients were followed for six months. A total of 245 patients were enrolled. Patients were surveyed on alcohol use at enrollment and their clinical encounters were captured routinely as part of standard care for follow up period of six months. The study is currently in the data analysis phase.

Contact: Patrick Oyaro,

Maurice Aluda,

Pith Moromo 2: Health Consequences of Food and Nutrition Insecurity for Pregnant Women of Mixed HIV Status, and their Infants

In Kenya, there are at least 3.9 million individuals who are not food secure. Evidence suggests that HIV+ pregnant women and their infants are at particularly high risk for food insecurity, and that it has a multitude of negative effects on their nutritional status, disease burden, and psychosocial well-being. However, we do not have a good grasp of the prevalence and effects of food insecurity within this population. Pith Moromo is Luo for “enough to eat” and attempts to fill this knowledge gap. Pith Moromo 1 was designed as a formative, qualitative study in which in-depth interviews were conducted with pregnant and lactating women, household members, and key informants about the perceived causes and consequences of food insecurity during pregnancy and lactation. These interviews were used to inform Pith Moromo 2, a cohort study following 360 pregnant women of mixed HIV status (half HIV+, half HIV-) from their first ANC visit until 9 months post-partum. This study consists of multiple clinic visits, during which detailed questionnaires are conducted and anthropometric measurements (including height, weight, MUAC, four sets of skinfolds, and body composition) are taken. Once the baby is born, these questionnaires include topics such as infant diet and appetite, and anthropometric measures are conducted on both babies and mothers. Our findings about the mechanisms by which food insecurity is deleterious will be used to design and evaluate evidence-based interventions targeting food and nutrition insecurity within this vulnerable population.

Contact: Sera Young,

Maricianah Onono,


Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. Sequential adaptive strategies – a novel class of public health approaches – may offer a solution to optimize retention in resource-limited settings. A candidate sequential adaptive strategy would start with a less expensive intervention (e.g., SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to patients who show early signs of poor retention. This study involves a sequential multiple assignment randomized trial to evaluate a family of such strategies. This study will randomize 2,500 adults initiating antiretroviral treatment (ART) at 4 HIV clinics in the Nyanza region of Kenya to (1) standard of care routine education and counselling (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. The primary objective is to assess the comparative effectiveness of sequenced intervention strategies to prevent initial lapses in retention and to treat those that occur. The primary endpoint is alive and virologically suppressed two years after enrolment. In addition, we will assess the comparative effectiveness of first-stage strategies (REC, SMS, voucher) to prevent lapses in retention, and the comparative effectiveness of second stage strategies (outreach, SMS + voucher, navigator) to re-engage patients after initial lapse. At study conclusion our output will be a menu of adaptive strategies for retention, accompanied by estimates of cost and effectiveness, which policy makers in different settings can use to advance the impact of HIV care and treatment programs in Africa.

Contact: Elvin Geng,

Antiretroviral Choices among Couples Eligible for Prevention of HIV Transmission (ACCEPT):

Why do individuals in HIV serodiscordant partnerships who qualify for antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) accept or decline initiation of ART or PrEP in western Kenya?

Antiretroviral-based prevention tools, such as antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP), have demonstrated promising efficacy in prevention HIV transmission, including among heterosexual African HIV serodiscordant couples. Nearly 40% of new HIV infections occur within stable HIV serodiscordant couples in east Africa. Yet, when these options are offered, some individuals decline initiation of ART or PrEP. Identifying the fears, concerns, and barriers to initiating ART or PrEP are greatly important in realizing the public health impact of these antiretroviral-based prevention tools. ACCEPT uses qualitative research methods and is a substudy of an on-going parent study in Kisumu, Kenya called the Partners PrEP Demonstration Study. We are conducting in-depth interviews with individuals and couples enrolled in ACCEPT to determine reasons why individuals in stable, heterosexual HIV serodiscordant partnerships accept or decline ART or PrEP.

Contact: Rena Patel,

Impact of antiretroviral therapy’s influence on fertility desires, contraception, and pregnancy (ART-C)
The World Health Organization (WHO) in 2013 recommended increasing the CD4 cell count threshold from 350 to 500 cells/mm3 for antiretroviral therapy (ART) initiation in HIV-positive adults. The Kenya Ministry of Health adopted this recommendation and FACES has implemented this policy change starting July 2014. The impact of earlier ART initiation on fertility desires, contraceptive use, and subsequent pregnancy incidence in HIV-positive women in sub-Saharan Africa is unknown. ART-C is a “pre-post” study design utilizing mixed methods with quantitative and qualitative data from the FACES cohort to evaluate the impact of earlier ART initiation on reproductive health outcomes. Both facility-level assessments of FP services at HIV care clinics and in-depth interviews with HIV-positive women will be utilized to assess the impact of earlier ART initiation on reproductive health outcomes.

Contact: Rena Patel,

Development and Evaluation of a Safer Conception Training and Education Toolkit for the Empowerment of HIV-Affected Women, Couples and Healthcare Providers

For HIV-affected women and couples to fulfill their reproductive goals, they first need access to information on safer methods of conception. Health care providers have the responsibility of providing information to HIV-affected women and couples to help them safely conceive while minimizing the risk of sexual HIV transmission. This study aims to develop and evaluate a practical, concise, interactive Safer Conception Counseling Toolkit that will be used to train health care providers in FACES-MOH HIV clinics in safer conception strategies. Findings from this innovative, transdisciplinary research will assist in the development of a standardized safer conception counseling message provided by health care providers for HIV-affected couples and individuals, and will also guide policy and future scale-up of safer conception strategies in Kenya, and potentially throughout the region.

Contact: Okeoma Mmeje,

Male Partner Involvement in Safer Methods of Conception for HIV-Affected Couples: A Closer Look at Home Vaginal Insemination and Semen Collection

This qualitative study consists of semi-structured focus group discussions and in-depth interviews with HIV-serodiscordant couples enrolled in the vaginal insemination study to evaluate the challenges and role that gender dynamics have had on the acceptability of vaginal insemination as a safer method of conception. In addition, the study intends to understand how HIV-affected men and women view the use of assisted reproductive technology as a safer method of conception that may decrease the risk of sexual HIV transmission in couples desiring children. Specifically, the study is assessing the perceptions that HIV-infected men have about sperm washing coupled with intrauterine insemination, as an assisted reproductive technique with particular emphasis on semen collection and processing. Findings will help clinicians and researchers develop effective counseling and education messages that will promote the uptake and enhance the feasibility of safer methods of conception within the local cultural context.

Contact: Okeoma Mmeje,

The Use of a Novel Social Support Approach to Optimize Care Amongst HIV Infected Youth in Western Kenya
HIV is one of the leading causes of mortality amongst youth in sub-Saharan Africa (SSA). HIV-infected youth have unfavorable retention and medication adherence rates, compared to other populations. HIV-related stigma, lack of disclosure of HIV serostatus and poor social support directly impact HIV infected youth’s adherence to medications and retention in care.  The current study will explore the most effective ways to enlist social support for youth to aid in adapting an adherence and retention intervention for youth living with HIV and document baseline patterns of disclosure, social support, and levels of stigma amongst HIV infected youth in Kenya.  This is a mixed methods study that will recruit 200 HIV infected youth aged 15-24. The findings from this study will be used to determine how to adapt a successful intervention for youth and their social networks to build social support and improve disclosure, ultimately improving health outcomes.
Contact: Hilary Wolf,

Gender-Based Violence and HIV Outcomes: Tracking and Treating Mental Illness

This study is a clinical trial of mental health treatment (Interpersonal Psychotherapy (IPT) x 12 weeks) delivered by community therapists for HIV+ women served by FACES who are affected by Gender-Based Violence (GBV) and have depression and Posttraumatic Stress Disorder (PTSD). Primary outcome measures of the study include mental health, HIV treatment adherence and HIV viral load.  Secondary outcomes are interpersonal functioning, including re-victimization, and cost-benefit analyses.  The sample size is ~200.  This study launched in January 2015 with an expected duration of approximately 2 years.  This pilot study will provide data on feasibility and acceptability, as well as efficacy trends. Feasibility will be assessed with respect to (1) IPT training, supervision, fidelity monitoring and delivery and (2) participant recruitment, retention, and evaluation. Acceptability of the intervention content and delivery will be assessed in semi-structured closing interviews with participants and study therapists.

Contact: Susan Meffert,

A Home Based Couples Intervention to Enhance PMTCT and Family Health in Kenya
HIV-related maternal deaths and infant HIV infection remain unacceptably high across sub-Saharan Africa. Prevention of mother-to-child transmission (PMTCT) requires a complex series of interventions throughout pregnancy and after birth. Drop-offs can occur in this PMTCT cascade if women refuse HIV testing, do not disclose their HIV status, or avoid health services because they fear negative consequences for their relationship with their male partner. Engaging both partners of a couple during pregnancy has the potential to enhance health decisions, increase healthcare utilization, and ultimately improve maternal, paternal, and infant health. The goal of this study is to develop and pilot a home-based couple’s intervention that includes safe HIV testing and disclosure for couples, alongside support for family health. We will adapt evidence-based Couples HIV Counseling and Testing (CHCT) protocols for the needs of pregnant couples and train lay health workers to deliver this service as part of home visits. Building on preliminary studies, we have collected further formative data via in-depth interviews and focus groups and are in the process of translating our findings into a viable intervention model together with local stakeholders. We will then conduct a pilot study, in which we will randomize pregnant women at two antenatal clinics to the home-based intervention or standard care, and follow them and their male partners until three months after the birth of the baby. Results will provide evidence of the preliminary impact, acceptability, and feasibility of the intervention and the study methods, which will allow us to develop an efficacy trial. This study is currently ongoing and has been funded by the US National Institute of Mental Health.

Contact: Janet Turan,

Maximizing Adherence and Retention in Women and Infants in the Context of Option B+ in Kenya
As Option B+ is scaled up in Kenya, it is essential to identify effective methods to ensure long-term adherence and retention in care for mother-baby pairs, throughout pregnancy, breastfeeding, and beyond. Our study is currently being conducted at 20 health facilities and associated communities in Kisumu, Homabay and Migori Counties, Kenya where mother to child transmission (MTCT) rates prior to Option B+ rollout remain near 10% (higher than the national prevalence), despite the wide availability of PMTCT services. To gain understanding of and address potential barriers at the individual, community, and health facility levels, formative research in the form of in-depth interviews and focus groups with HIV-positive pregnant and postpartum women, their male partners, and health care providers were conducted. This information will be used to refine two proposed interventions, which will be rigorously tested, using a two-by-two factorial cluster randomized trial. The evidence-based interventions to be tested will include 1) community Mentor Mothers (cMM) who will provide support for ART adherence and retention in care for HIV-positive women in the community and 2) individually tailored, theory-based mobile phone text messages. Results from this study will inform the scale-up of Option B+ in Kenya by identifying effective interventions that can maximize the potential of Option B+ with the aims of reaching the elimination of MTCT of HIV and significantly improving maternal health. This study is currently ongoing and has been funded by the US National Institute of Child Health and Human Development.

Contact: Lisa Abuogi,
                Janet Turan,

SToP Crypto: Treatment of Early Cryptococcal Infection
In sub-Saharan Africa and southeast Asia, invasive cryptococcal disease is the second most common life-threatening HIV-associated opportunistic infection after tuberculosis and is responsible for up to 20% of deaths. Since invasive cryptococcal disease primarily affects HIV-infected individuals with advanced immunosuppression, one potential strategy to detect early cryptococcal infection in resource-limited settings is to screen asymptomatic individuals with advanced HIV-related immunosuppression for serum cryptococcal antigen (CrAg) as they enter outpatient HIV care andtreatment programs. Preliminary evidence suggests that fluconazole monotherapy is not an effective treatment in a heterogeneous population of individuals with early cryptococcal infection. This phase IIb clinical trial is designed to provide a screening evaluation for the hypothesis that combination therapy with fluconazole and flucytosine improves survival as compared to fluconazole alone for the treatment of early cryptococcal infection in HIV-infected individuals with advanced immunosuppression. This study is funded through an R21 through the National Institute of Neurological Disorders and Stroke and Fogarty International Center through the National Institutes of Health.

Contact: Ana-Claire

THINK2: ART treatment effects on HIV-associated neurocognitive impairment
HIV-associated neurocognitive disorder (HAND) is a prevalent disorder in HIV-infected individuals worldwide. We will enroll a prospective observational cohort of 200 HIV-infected ART-naïve adults with and without HIV-associated cognitive impairment and compare their social, clinical and economic outcomes. This study is funded by a K01 through the Fogarty International Center of the National Institutes of Health

Contact: Ana-Claire

Sustainable East Africa Research on Community Health (SEARCH)
The SEARCH study will quantify the health, economic and educational impact of early HIV diagnosis and immediate ART treatment using a streamlined care delivery system in rural communities in East Africa. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most “at risk” and build upon evidence based prevention interventions including adult male circumcision.   SEARCH is a cluster randomized community trial. Annual community health campaigns will be conducted in all study communities and will offer HIV testing and multi-disease prevention and treatment services. The intervention is ART independent of CD4 cell count delivered in a streamlined approach for all HIV infected adults and children. Components of streamlined care include ongoing HIV combination prevention strategies including male circumcision. Control communities will receive annual testing campaigns and ART will follow CD4-driven country guidelines.  The study will begin in 2013.

Contact: Rachel

Identifying Opportunities for HIV Prevention among Female Migrants in Kenya
This study aims to assess the degree to which women’s participation in migration in Southern and East Africa contributes to HIV/AIDS in the regions.  It also seeks to characterize features of the contexts of African women’s migration experiences- and the behavioral and mental health consequences of migration- that place female migrants at particularly high risk of HIV infection and transmission. This study is comprised of two distinct phases: a secondary data analysis using population-based survey and HIV serological data from Southern and East Africa, and an in-depth qualitative study in Kenya.  The ultimate goal of this research is to reduce HIV transmission risks via a multi-level HIV prevention intervention with female migrants in western Kenya. This study is funded by a National Institutes of Health K01 mentored research scientist development award.

Contact: Carol Camlin,

Cervical Cancer Screening and Treatment in HIV-infected Women in Kenya 
Cervical cancer and HIV are intersecting epidemics that both disproportionately affect low-income women.  The impact of the socioeconomic disparity and biologic synergy of these two diseases is seen dramatically in Kenya, where cervical cancer is the most common cancer killer.  Two potentially low-cost and effective cervical cancer screening methods are currently being tested: visual inspection with acetic acid (VIA) and protein biomarkers expressed in the presence of cervical dysplasia.  Additionally, the potential impact of the presence, diagnosis and treatment of HPV-related dysplasia on HIV genital shedding (a major risk factor for HIV transmission) is being studied.  This research is funded by the National Institutes of Health through the UCSF-GIVI Center for AIDS Research and UCSF Clinical and Translational Science Institute.

Contact: Megan

Effect of HAART on Surgically Treated HGCIN in HIV-infected Women
This study is being carried out to assess the effect of Highly Active Antiretroviral Therapy (HAART) on the recurrence of surgically treated High-Grade Cervical Intraephithelial Neoplasia (HGCIN) in HIV-infected women in Kenya. This is a prospective cohort study of HIV-infected women receiving care in the city of Kisumu. Women with HGCIN are being followed for two years after their initial surgical excision to determine the effect of HAART on the recurrence of HGCIN after surgical excisionThis study is funded through UCSF discretionary funds, including private donations.

Contact: Megan

International Epidemiologic Databases to Evaluate AIDS (IeDEA) 
IeDEA is striving to build regional population-based HIV knowledge and information. IeDEA is pooling data from collaborating provider and research networks in East Africa to cost-effectively generate large data sets to address high priority research questions. Data collection, merging, storage, and sharing across sites in the East African Region, is focusing on:

  • cost-effectiveness of HIV care, treatment, and prevention strategies;
  • appropriate guidelines for initiation of first-line therapy for treatment of HIV/AIDS;
  • genetic variability of HIV;
  • issues related to first-line therapy failure;
  • adherence to HIV treatment;
  • contextual issues and resource limitations of HIV care delivery in resource-limited settings;
  • impact of tuberculosis infection on HIV/AIDS care and treatment in developing world;
  • prevention of mother-to-child transmission of HIV

This study is supported by NIH through Indiana University.

Contact: Jayne Kulzer,

Texting to Improve Testing (TextIT): A Cluster Randomized Stepped Wedge Trial of Text Messaging to Improve Postpartum Retention in Care and Early Infant Diagnosis of HIV

There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. This study is examining, in a randomized controlled trial, the effect of text messages sent to women enrolled in PMTCT programs on improving adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings. It is funded by the National Institutes of Health through the Fogarty International Clinical Research Fellowship Program at Vanderbilt University.

Contact: Thomas Odeny,

Integrated Community Case Management (iCCM) Study

The iCCM Study is an implementation research project implemented in Homabay County. The study is aimed at determining whether trained, supervised and well supplied community health workers in hard to reach areas such as Homabay County can correctly perform iCCM and increase the proportion of children under five years receiving antibiotics for pneumonia, artementher-lumefantrine for malaria and zinc and oral rehydration therapy for diarrhea by 20% compared to the baseline. The study is still at its implementation stage, though as of January 2015 the community health workers had thus far treated 26,200 children with diarrhea, 14,140 with pneumonia and 6,200 with malaria at household level in the hard to reach areas.

Contact: Maricianah Onono,

Maternal Newborn Health (MNH) Program

The MNH Program started on January 2015, will cover the entire Homabay County. The MNH Program is intended to contribute to the reduction in maternal and neonatal morbidity and mortality by increasing access to community based MNH services, increasing community knowledge and inducing behaviour change and modification with regard to key maternal and neonatal high impact interventions.

The objective is to determine whether an integrated community based maternal and newborn health package consisting of maternal and neonatal health packs, home-based health education and routine neonatal assessment, trainings and community mobilization reduces prenatal and all cause neonatal mortality rate by 20% or more.

Contact: Maricianah Onono,

Evaluating a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya

This is a two-phase cluster-randomized trial of implementation strategies for a Ministry of Health and WHO-recommended cervical cancer prevention protocol in western Kenya. During Phase 1, communities will be randomized to HPV-testing in either community-health campaigns or clinics, with standard referral for treatment of HPV+ women to government facilities. We will use the RE-AIM framework, a framework used to evaluate implementation strategies, (Reach, Efficacy, Adoption, Implementation consistency and costs, and Maintenance) to assess the key outcomes and then work in partnership with the community to develop a strategy for enhanced linkage to care. In Phase 2, all communities will offer community-based testing with enhanced linkage to care. Conducting this cluster-randomized trial will enable us to look at the proportion of women in each community who get cervical cancer screening, the gain in treatment access with enhanced linkage to care and the cost-effectiveness of the two interventions. The RE-AIM framework will allow us to measure and refine the context-specific dimensions of the project to produce a “toolkit” for scale-up within this region and implementation into similar settings.

Contact: Megan Huchko,

The Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial

The goal is to answer the public health question of the relative risks (HIV acquisition) and benefits (pregnancy prevention) of three commonly-used and effective contraceptive methods among women. This study aims to compare the risks of HIV acquisition between women randomized to DMPA, levonorgestrel (LNG) implant, and copper IUDs. There are 14 sites across Eastern and Southern Africa, two of which are in Kisumu.

Contact: Elizabeth Bukusi,

Maricianah Onono,

Stella Njuguna,

SANOFI Malaria

The goal is to investigate the efficacy, safety, tolerability and pharmacokinetics of a single dose regimen of Ferroquine (FQ) with Artefenomel (OZ439) in adults and children with uncomplicated Plasmodium falciparum malaria. This study aims to determine whether a single dose combination of OZ439/FQ is an efficacious treatment for uncomplicated P. falciparum malaria in adults and children.

Contact: Maricianah Onono,

Elizabeth Bukusi,

Patricia On’gwen,

Josephine Odoyo,


The goal is to compare the activity and safety of Dolutegravir (DTG) to the standard lopinavir/ritonavir regimen. Both regimens will be administered with dual nucleoside reverse transcriptase inhibitor therapy to HIV-1 infected adult subjects with treatment failure on first line therapy. This study aims to demonstrate non-inferior antiviral activity at 48 weeks of a DTG containing regimen (DTG 50 mg once daily + two NRTIs) compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV + two NRTIs.

Contact: Maricianah Onono,

Josephine Odoyo,