Research

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FACES Research Studies

This research list was last updated in November 2014. To download this summary as a PDF, click here.

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, jmturan@uab.edu



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, lisa.abuogi@childrenscolorado.org
                    Janet Turan, jmturan@uab.edu


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 Meyer, ana-claire.meyer@yale.edu


THINK2: ART treatment effects on HIV-associated neurocognitive impairment
HIV-associated neurocognitive disorder (HAND) is a prevalent disorder in HIV infected individuals world wide. 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 Meyer, ana-claire.meyer@yale.edu


Women’s HIV Mental Health Care Needs Assessment Study (WIN)
This study uses qualitative methods to identify (1) mental health and Anti-Retroviral (ARV) adherence characteristics; (2) need for depression and PTSD care and; (3) empowerment factors that may influence ability to obtain mental health treatment among HIV+ women affected by Gender-Based Violence (GBV) (HIV+GBV+) in Nyanza Province, Kenya. Interviews and focus groups of HIV+ women and local healthcare providers will assess HIV+GBV+ women for symptoms of depression and PTSD, social functioning, barriers to mental health care and mental health treatment content and delivery preferences. The resulting data will inform our design of a mental health intervention for HIV+GBV+ women treated by Family AIDS Care and Education Services (FACES) that remediates the effects of GBV on mental illness and disempowerment, and is delivered in a way that is acceptable and feasible for the local culture. We will use this data to apply for R series funding to test this treatment via a clinical trial at FACES. This study is funded by a BIRCWH K award as well as a GHS Burke grant.

Contact: Susan Meffert, SusanM@lppi.ucsf.edu


EMPOWER
The EMPOWER study is an exploratory study to identify interventions to engage men in family planning and ultimately empower women, thereby meeting the unmet need for family planning, helping women to avoid unwanted births and improving women’s reproductive health outcomes. The ultimate goal of the project is to identify a gender transformative intervention model that is acceptable and suggested by community members that can be piloted in the future and ultimately tested to evaluate the impact of male empowerment in the area of family planning on female empowerment and contraception use.

Contact: Sara Newmann, Newmanns@obgyn.ucsf.edu


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 Steinfeld, steinfeldr@globalhealth.ucsf.edu


Lost to Follow-up from Care in HIV Positive Adolescents in Kisumu, Kenya
Adolescents represent 60% of all new HIV infections in sub-Saharan Africa.  However, a significant proportion of HIV+ adolescents become lost to follow-up (LTFU), placing them at increased risk for HIV-related morbidity and mortality. Research has suggested that the school environment, specifically school-based stigma, discrimination, and disclosure, may play an important role in uptake and retention in HIV care by adolescents. Our multi-disciplinary collaborative group, based at KEMRI and at UCSF, will employ qualitative methods to explore: (1) the multi-level determinants why adolescents become LTFU in Kisumu, Kenya and (2) the role the secondary school environment plays among HIV+ adolescents who are LTFU. We will conduct: (1) focus groups with HIV+ adolescent peer educators who work with LTFU adolescents and are in care, (2) semi-structured interviews with HIV+ adolescents who are LTFU, and (3) semi-structured interviews with student-nominated teachers and administrators from local secondary schools. The purpose of these interviews and focus groups will be to better understand the barriers adolescents have in accessing HIV care and how the school environment may affect adolescents’ ability to positively or negatively access and remain in care. Information regarding the multi-level determinants of LTFU among adolescents and specifically of the school-based environment will inform the development of interventions to improve the retention of East African adolescent in healthcare. This study is funded through the UCGHI GloCal Health Fellowship at UCSF.

Contact: Hilary Wolf, wolfhi@peds.ucsf.edu


Engagement in Care among HIV-Infected Patients in Resource-Limited Settings
This study assesses the magnitude of and reasons for failure to engage in care among HIV-infected patients in the East Africa International Epidemiologic Databases to Evaluate AIDS (IeDEA) Consortium. This study aims to optimize the validity of a sampling-based approach to estimating failure to retain in care and failure to initiate ART in diverse settings. This study will also use the sampling-based approach to estimate the fraction of ART-eligible patients who fail to initiate, and the fraction of patients on ART who fail to be retained in care in 11 diverse clinics in the East Africa IeDEA consortium.  This study is funded by a supplement from IeDEA as well as funds from the UCSF Center for AIDS Research (CFAR).
Contact: Elvin Geng, genge@php.ucsf.edu


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, Carol.Camlin@ucsf.edu


Prevention of Tuberculosis in HIV-Infected Children
This study is being carried out in Kenya to evaluate the effectiveness of Isoniazid Preventive Therapy (IPT) in HIV-infected children to reduce TB incidence, morbidity and mortality. The hypothesis is that IPT will effectively reduce TB and overall morbidity and mortality in the study population. If this should occur, the Kenya National Leprosy and Tuberculosis Program can consider national guidelines for IPT in children. This study is funded through UCSF discretionary funds, including private donations.

Contact: Lisa Dillabaugh, DillabaughL@peds.ucsf.edu


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 Huchko, Megan.Huchko@ucsf.edu


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 IntraephithelialNeoplasia (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 excision. This study is funded through UCSF discretionary funds, including private donations.

Contact: Megan Huchko, Megan.Huchko@ucsf.edu


Integration of Family Planning Services into HIV Care and Treatment
This study is being conducted to determine how to best meet the family planning needs of HIV-infected women in Kenya. It is a cluster-randomized trial comparing the effects of integrating family planning services into HIV care and treatment programs in Nyanza Province, Kenya, with the standard referral for family planning services outside of HIV care and treatment programs. The study is specifically looking at contraceptive uptake, contraceptive continuation, and unintended pregnancy rates. This study is funded by the Tides and Gates Foundations.

Contact: Sara Newmann, Newmanns@obgyn.ucsf.edu


International Epidemiologic Databases to Evaluate AIDS (IeDEA)
IeDEAis striving to build regional population-based HIV knowledge and information. IeDEAis 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, jkulzer@globalhealth.ucsf.edu


ART treatment effects on HIV-associated neurocognitive impairment
Combination ART is the most effective treatment for HIV-associated neurocognitive disorder(HAND) to date and some studies have suggested that ART with higher penetration into the central nervous system (CNS) leads to improved neurologic outcomes.  However, these studies have important limitations and thus there is insufficient evidence to recommend ART with high CNS penetration effectiveness (CPE) for the treatment of HAND.  The objective of this application is to determine whether it is important to treat HIV-infected individuals with neurocognitive disorders with ART with high CPE. Because of limited ART choices in Kenya, we will be able to directly compare the effects of specific ART regimens thus avoiding the limitations of prior studies.  The central hypothesis is that, among individuals with HAND, ART with high CPE leads to improved neurologic outcomes as compared to ART with low CPE.  We will enroll a prospective observational cohort of 200 HIV-infected ART-naïve adults with HIV-associated cognitive impairment.  This study is funded by a K01 through the Fogarty International Center of the National Institutes of Health.

Contact: Ana-Claire Meyer, meyerac@sfgh.ucsf.edu

 


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 and treatment 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 Meyer, meyerac@sfgh.ucsf.edu


Acceptability, Feasibility and Efficacy of Vaginal Insemination for Conception in HIV Discordant Couples Desiring Pregnancy in Kenya
This study will evaluate the acceptability, feasibility and efficacy of vaginal insemination with semen for conception among HIV discordant relationships (female positive ♀+, male negative ♂-) in Kenya.  Couples desiring pregnancy will receive targeted reproductive counseling for six months.  Consistent condom use will be emphasized and couples will be taught assisted vaginal insemination for conception. It is hoped that the findings of this study will provide evidence to support the routine use of vaginal insemination as a safe method of conception in (♀+/♂-) HIV discordant couples desiring children.  This study is of significant public health importance because the use of vaginal insemination for conception in ♀+/♂- HIV discordant couples is expected to reduce the likelihood of riskier sexual practices for childbearing and decrease the incidence of HIV in sub-Saharan Africa. This study is funded by a RAP pilot award from the UCSF-GIVI Center for AIDS Research.

Contact: Okeoma Mmeje, MmejeO@globalhealth.ucsf.edu


Integration of Family Planning Services into HIV Care and Treatment
This study is being conducted to determine how to best meet the family planning needs of HIV-infected women in Kenya.  It is a cluster-randomized trial comparing the effects of integrating family planning services into HIV care and treatment programs in Nyanza Province, Kenya, with the standard referral for family planning services outside of HIV care and treatment programs.  The study is specifically looking at contraceptive uptake, contraceptive continuation, and unintended pregnancy rates.  This study is funded by the Tides and Gates Foundations and the Bill & Melinda Gates Foundation.

Contact: Sara Newmann, Newmanns@obgyn.ucsf.edu


Fertility Desires and Family Planning among HIV-Infected Couples
This study is exploring decision-making and relationship power around fertility and family planning among HIV-affected couples and community leaders in Nyanza Province, Kenya. This is a qualitative, hypothesis-generating research project which involves in-depth, open-ended interviews with couples who present to HIV clinics for care, couples from high prevalence HIV communities, and individual community leaders. The study is funded by the Hellman Foundation and by the Center for AIDS Research at UCSF.

Contact: Sara Newmann, Newmanns@obgyn.ucsf.edu


Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: A Randomized Trial of a Text Messaging Intervention

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, odeny@uw.edu


Application of weighted time-series to address bias in evaluation of clinic- and community-level research
The study is using a simulation to develop, test, and apply new analytic methods (weighted time-series) for evaluation the effectiveness of community- and clinic-level interventions. It will then compare results using weighted time-series and conventional methods within the context of a clinic-level intervention, namely at FACES-supported clinics in Kenya. The results of this study will be used to seek funding to test the broader application of these methods in both community- and clinic-level interventions. Application of these methods has the potential to improve evaluation of many community-level interventions, particularly in settings where it is difficult to obtain individual-level information or to follow individuals in the community over time (e.g. rural or other hard to reach populations). The study is funded through UCSF Center for AIDS Prevention Studies (CAPS) Innovative Grants.

Contact: Starley Shade, sshade@php.ucsf.edu


 

 

Pilot agricultural intervention for food security and HIV health outcomes in Kenya
Food insecurity contributes to increased HIV transmission risk and higher HIV-related morbidity and mortality.  This pilot study will test the hypothesis that a multi-sectoral agricultural intervention will prevent HAART treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk.  One hundred and twenty HIV-infected farmers on HAART in Western Kenya (68at an intervention clinic and 72at a control clinic) will be enrolled and followed for 1 year. This intervention will include: a) human-powered water pumps and other required farm commodities, b) microfinance loans (~$75) to purchase the pump and agricultural implements, and c) education in sustainable farming practices. The impacts of the intervention on mediating factors (food security and economic indicators) will be examined, and pathways for how improvements in these mediating factors impact health outcomes will be explored. The ultimate goal of this work is to contribute to sustainable solutions to tackle the intersecting challenges of food insecurity, poverty, and HIV/AIDS in sub-Saharan Africa. This study is funded by a National Institutes of Health/National Institute of Mental Health R34 grant.

Contact: Sheri Weiser, Sheri.Weiser@ucsf.edu


FACES Study Partner for Patients in Need of HIV Care and Treatment Referral and Services

(PrEP) Parallel Comparison of Tenofovir and Emtricitabine/tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples

This study addresses the need for novel strategies to prevent HIV-transmission within discordant couples. UCSF-KEMRI is one of nine sites in this multi-site trial that is funded by the Gates Foundation and coordinated by the University of Washington. USCF-KEMRI maintains one site in Kisumu, Kenya.

This study is a double-blind, placebo-controlled, phase III clinical trial toassess the safety and efficacy of taking once-daily pre-exposure prophylaxis (PrEP) for the prevention of HIV infection, using theantiretroviral medication tenofovir (TDF), either alone or in combination with emtricitabine(FTC/TDF).This study hypothesizes that PrEP will decrease HIV-1 acquisition among HIV-uninfected individuals within HIV discordant couples, if found to be safe and efficacious.

This study enrolled 4,758 HIV discordant couples across the nine sites in Kenya and Uganda.  Enrollment started in July 2008 and ended in November 2010; some study participants remain in follow up.  The HIV-1 infected partners were randomly assigned to one of three study arms: 1) TDF), 2) FTC/TDF, or 3) placebo. All study participants received a comprehensive package of HIV prevention services, whichincluded intensive safer sex counseling (both individually and as a couple), HIV testing, freecondoms, testing and treatment for sexually transmitted infections, and monitoring and carefor HIV infection.

By 31 May 2011, a total of 78 HIV infections occurred in the study: 18 among thoseassigned TDF, 13 among those assigned FTC/TDF, and 47 among those assigned placebo.Thus, those who received TDF had an average of 62% fewer HIV infections (95% CI 34 to78, p=0.0003) and those who received FTC/TDF had 73% fewer HIV infections (95% CI 49to 85, p<0.0001) than those who received placebo. PrEP, both TDF and FTC/TDF, reduced HIV risk in womenand men.PrEP was also found to be safe: the rate of serious medical events was similar for those assigned to TDF, FTC/TDF, and placebo. Due to these exciting findings study participants originally in the placebo arm will now be re-enrolled and able to receive one of the two intervention arms. The study will continue; it is important to determine if safety or HIV preventioneffects are sufficiently different for TDF versus FTC/TDF to warrant one or the other beingwidely implemented for HIV prevention.

Contact: Jayne Kulzer, jkulzer@globalhealth.ucsf.edu