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Projects

FPD pride itself for making a valuable contribution to society by conducting numerous research projects with the goal of enhancing modernday medical knowledge.

1. Investigating the acceptability, and feasibility of home-based TB testing of household contacts using a new, mobile point of care technology

Background and Study aims

Missed TB cases are a critical global health problem. There are three main reasons for missed cases:1) People with TB may not access health care at all, 2) People with TB may have access to health care services but are not diagnosed, and 3) People with TB may get diagnosed but are not documented. Ongoing research by our team demonstrates that missed opportunities to screen for TB in primary and community health clinics significantly contribute to missing TB cases in South Africa. Active case finding and household contact investigations have the potential to greatly expand and improve early case detection in this WHO-defined high-risk population. In response to the urgent need for new, cost effective interventions and strategies to find and link-to-care missing cases of TB from the community, we propose an exploratory study with these specific aims:

1) To investigate the acceptability and feasibility of home-based TB testing of household contacts using a new portable GeneXpertpoint-of-care (PoC) Omni platform with wireless linkage to a national TB database, and

2) To determine the potential impact of such a home-based testing program on early detection of TB disease and linkage-to-care (LTC)

We hypothesize that among household contacts of TB patients, home-based point-of-care TB testing will increase early detection and linkage-to-care, and decrease time-to-treatment initiation of secondary TB cases compared to standard home-based TB symptom screening with referral for testing.

Method

Clinic-based research assistants (RA-C) will identify and seek for consent to partake in the study from all GeneXpert positive pulmonary TB (PTB) index patients initiating treatment at the selected health facilities. Enrolled index participants will be randomly assigned to an intervention group that will offer TB symptomatic household members a home-based GeneXpert MTB/RIF TB test with immediate referral of TB positive cases to the clinic for treatment initiation while symptomatic household members in the comparison group will receive standard home-based TB symptom screening with immediate referral for testing at the health facility. Eligibility criteria for enrolling household participants include: 1) TB symptomatic household contacts; 2) not currently on TB treatment; 3) able to produce a sputum specimen for testing; 4) age =6 years; and 5) provision of written consent.

Potential Impact of Study

This proposed study has the potential to enhance early detection and linkage-to-care of household contacts, inform strategies for the use of PoC molecular diagnostics to conduct community- and home-based TB testing, decrease the underreporting of TB cases and streamline processes for linking TB infected individuals to care. Furthermore, findings may influence clinical and public health practices in other low and middle-income countries relating to TB case finding. Finally, if shown to be acceptable, feasible, and potentially efficacious, this pilot intervention will serve as the basis for a larger controlled study in the future.

2. Assessment of mental health care services provided in public health clinics in four districts in SA, 2016

Background and Study aims

In 2012, the South African National Department of Health (NDoH) developed the 2013-2030 National Mental Health Policy Framework and Strategic Plan, which reasserted the principle that mental health is an integral element of overall health. Mental disorders are an important contributor to the disease burden in South Africa; almost 1 in 3 South Africans have been diagnosed with a mental health disorder at some point in their lifetime, with anxiety disorders ranking as the most common type of disorder.

There is a need to integrate mental health services into routine care of chronic diseases. Individuals with physical health conditions have an increased risk of having a mental disorder compared with the general population. People who have co-morbid depression and tuberculosis (TB) disease are at a higher risk for treatment non-adherence, as well as higher morbidity and mortality rates. By diagnosing and adequately managing mental disorders, health outcomes of patients may improve.

Method

Nkangala is one of four districts selected to conduct an assessment of mental health care services provided in public health clinics in SA; the other districts are Tshwane, Capricorn and Buffalo City Metropolitan (BCM). The mental health services provided to patients seeking tuberculosis (TB) care will be assessed within the Nkangala District (TB incidence of 355/100,000).

Interviews will be conducted with key district managers and health care workers (HCWs) within the district. District managers that will be interviewed include the TB District Manager and the Mental Health (portfolio) District Manager. District Manager interviews will aim to determine the managers perceptions of the impact of mental health illnesses on the TB programme, mental health services provided throughout the district, opportunities for staff development and training regarding mental health, and integration of mental health services.

Ten clinics - five Primary Health Care (PHC) and five Community Health Care (CHC) clinics - will be selected for the HCW interviews. For each clinic, one TB nurse and two or three mental health practitioners a lower level specialist (such as a counsellor, social worker or mental health nurse), and a higher level specialist, (such as a psychologist or psychiatrist), will be interviewed. Interviews with the HCWs will focus on determining the processes and procedures for mental health screening, diagnosis and referral.

Potential Impact of Study

In South Africa, there has been heavy reliance on psychiatric hospitals for the care and management of patients with a mental health illness. Existing public sector mental health care services are least accessible to the most vulnerable populations, and trained mental health professionals are disproportionately located in urban areas. There is a need to improve mental health services in primary care settings. In low-and middle-income countries, depression can be adequately treated by psychological interventions (such as cognitive behavior therapy or interpersonal therapies) and/or anti-depressants. It was found that the cost-effectiveness of interventions for depression in primary care settings is comparable to the cost-effectiveness of anti-retroviral treatment for HIV/AIDS.

3. Investigating the acceptability, feasibility and outcomes of home-based TB testing of household contacts using a new, mobile point of care technology.

Background and Study aims

The study aims to determine the acceptability and feasibility of using point-of-care technology (GeneXpert OMNI) to perform home-based TB testing of household contacts of TB patients and to describe the outcomes of household contacts screened and tested for TB in their home compared to those screened and referred for testing in a health facility. This study will recruit TB index patients from the 6 health facilities that serve the Duncan Village Informal Settlement Area (DVIS) in Buffalo City Metro Health District (BCM), Eastern Cape Province, South Africa, and TB screening and testing will be performed at households of TB patients. The findings from this project may represent a new strategy for increasing TB case finding and improving LTC for the 3 million missed cases of TB annually. Furthermore, early detection of TB disease, with improved LTC rates, may reduce TB transmission and prevalence in high-burden settings. Findings from this exploratory research could lay the foundation for multi-year research projects to establish the effectiveness of home-based TB testing on reducing TB morbidity and mortality

4. Do Integrated Models Work? A randomized study evaluating an intervention integrating economic strengthening and HIV prevention programs for vulnerable youth in South Africa.

Background and Study aims

At the request of the Prevention and Orphans and Vulnerable Children (OVC) Team of the Health Development Office of USAID South Africa, FHI 360's Accelerating Strategies for Practical Innovation & Research in Economic Strengthening (ASPIRES) project1 is carrying out a 4-year, $10 million program to improve the long-term economic security and HIV prevention knowledge and skills of atrisk youth in South Africa. ASPIRES will do so through the application of integrated combinations of evidence-based, gender-sensitive economic strengthening (ES) and HIV prevention education interventions, carried out in close collaboration with five PEPFAR Implementing Partners (IPs)2 who support or implement programs to assist OVC and their caregivers in South Africa. To build the evidence base around the efficacy of such interventions, ASPIRES will carry out rigorous qualitative and quantitative research.

Central to the project's research efforts is a study to assess whether the integration of an ES program with an HIV-prevention education program produces synergistic effects on economic and health outcomes. HIV prevention education has been shown to educate and build skills, which leads to safer sex practices and lower rates of sexually-transmitted infections (STIs), HIV, and unintended pregnancies. Economic strengthening interventions, such as financial education and savings, can reduce economic vulnerability and risk behaviours. This study seeks to identify if the combination of these two types of interventions leads to greater results than each intervention might have alone.

Study Objectives:

  • To assess whether the integration of an ES intervention with an HIV-prevention education intervention improves economic and health outcomes beyond singular interventions.
  • To estimate the resources required at the program level to support the ES and HIV-prevention education interventions.
  • To describe whether the interventions were perceived as effective in addressing economic and health outcomes and to describe how and why the interventions were perceived as effective or not

Method

ASPIRES will carry out a full factorial randomized controlled study with qualitative and costing subcomponents to answer the following question:

Does the integration of an ES program with an HIV-prevention education program produce synergistic effects on economic and health outcomes?

This study will be conducted in four communities in the greater Pretoria area where one of the IPs - Future Families - currently operates. Two thousand youth beneficiaries of Future Families aged 14 - 17 will be randomly assigned to one of four arms (500 each): ES intervention only, HIV prevention education only, ES + HIV prevention education combined, and no intervention (control). Participants in all four arms (including the control) will receive Future Families' standard package of services during the study.

ASPIRES will conduct quantitative in-person surveys and test for STIs and pregnancy among youth study participants before Future Families implements the interventions (baseline) and about nine months after Future Families starts the interventions (endline 1) and then again about 18 months after Future Families starts the interventions (endline 2). Additionally, ASPIRES will conduct explanatory qualitative research around the time of each quantitative endline survey.

To get in-depth perceptions of whether the programs were effective, and if so or if not, how and why. Qualitative research will be conducted with a randomly selected sub-sample of youth participants, their caregivers, and randomly selected Future Families program staff. Finally, ASPIRES will collect program implementation and costing data throughout the implementation of the interventions from Future Families. Results are expected by mid-2018.

Study Outcomes

The primary outcome being measured in this study is the prevalence of gonorrhea, trichomoniasis or chlamydia infection. These STIs are proxy measures for engaging in unprotected sex and were selected because they are common and can be tested in urine samples obtained from both males and females.

The secondary outcomes being measured (all self-reported, except pregnancy) are:

  1. Prevalence of pregnancy;
  2. Percent of adolescents engaging in protective sexual behavior, defined as self-reported abstinence or consistent condom use (a condom used every time) over the past six months;
  3. Engaging in transactional sex in the past six months;
  4. Two or more sexual partners in the past six months;
  5. HIV knowledge;
  6. Financial literacy;
  7. Participation in a savings group;
  8. Opening a savings account;
  9. Total amount of savings in past year;
  10. Saving for education;
  11. Caregiver providing youth money for savings; and
  12. Participation in household budgeting.

5. Validation of TB stigma scales in Buffalo City Metropolitan, Nkangala and Tshwane Districts in South Africa.

Background and Study aims

TB is associated with high levels of stigma due to its association with HIV/AIDS. TB related stigma is one of the major social factors that contributes to patients delay in seeking diagnosis and treatment, poor adherence to treatment leading to the propagation of the epidemic. More research has been done on assessing HIV/AIDS-related stigma quantitatively using scales while fewer studies have quantitatively assessed TB-related stigma in Africa. To adequately assess and understand the role of TB-related stigma in TB management, we need to measure stigma using validated tools. The Explanatory Model Interview Catalogue (EMIC) and Van Rie et al TB-related stigma scales have been validated and used primarily in the Americas and Southeast Asia; Malawi was the only African country in which the EMIC TB stigma scale was used. We propose to assess the psychometric properties of the Van Rie and the EMIC TB stigma scales for future use in the South African context.

  • To ensure the original scale concepts are retained after cross-cultural translation
  • To assess the psychometric properties of the TB stigma scales (internal consistency, construct validity, agreement, reliability)

Methods:

A cross sectional study will be conducted in Buffalo City Metropolitan, Nkangala and Tshwane Districts at primary health care facilities. Eight individuals for each participant type aged > 18 years (TB patient, TB suspect, and community member), in each of the seven selected languages (168 in total) will be purposively selected from study sites and invited to participate in in-depth cognitive interviews. Cognitive interviews will be done to assess if participants understood accurately the concepts asked in the TB stigma scales, thus ensuring content validity of the scales. Approximately a further 150 TB suspects, 150 TB cases on treatment and 150 community members aged > 18 years will be purposively selected and invited to participate in the quantitative survey. Community members exclude TB household contacts specifically accompanying TB patients on the day of enrolment All participants for cognitive and quantitative surveys will complete an interviewer-administered questionnaire with the following sections: demographic information, clinical information, depression, social support, HIV stigma, and the Van Rie and EMIC TB stigma scales. Psychometric analyses will be done to assess construct validity and reliability.

Potential Impact of Study:

Our study will support the formation of time and culture specific stigma scales that can be used to investigate TB related stigma quantitatively in multiple local contexts. The findings from future studies will assist in understanding the effects of stigma on public health programmes over time and directly inform the development of strategic interventions aimed at addressing stigma consequences. This work is in support of the Foundation for Professional Development (FPD)‘s district Health Systems Strengthening core activities.

6. Pilot Study of Sexually Transmitted Infection Screening for Prevention of Mother-to-Child-Transmission of HIV

This pilot study is assessing the acceptability and feasibility of screening for Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis infections among HIV-infected pregnant women, and the potential impact of a screening program on adverse pregnancy outcomes and MTCT of HIV infection. Prior research has demonstrated that NG and CT infections doubled the risk of mother-to-child HIV transmission. With one of the largest numbers of HIV-infected pregnant women delivering annually in the world (>300 000), both adverse birth outcomes and HIV MTCT are significant public health problems in South Africa; despite this, few studies have systematically measured the role of STIs and adverse birth outcomes in HIV-infected South African women.

There are four specific aims of the study are:
1. to determine the acceptability and feasibility of screening and treating HIV-infected pregnant women for CT, NG and TV at the first antenatal visit;
2. to describe longitudinal birth and neonatal outcomes of HIV-infected pregnant women;
3. to characterize vaginal microbiota of HIV-infected pregnant women, and nasopharyngeal and oral microbiota of their neonates; and
4. to investigate factors associated with treatment failure and re-infection among treated for CT, NG and TV.

The study seeks to enroll 1200 HIV-infected pregnant women into groups – an intervention group (N=600) and a control group (N=600). Intervention group participants are enrolled during their first antenatal visit for their current pregnancy and get tested for CT, NG and TV using Xpert® assays during this visit and again during the first postnatal clinic visit. Control group participants are enrolled during follow-up antenatal visits and are only tested for CT, NG and TV during their first postnatal clinic visits. Recruitment is being carried out at three primary care facilities in Soshanguve (KT Motubatse Clinic and Soshanguve CHC) and Mamelodi (Stanza Bopape CHC). To date (1 June 2016 to 31 December 2016) 344 participants have been enrolled into the study and it is projected that the target sample size will be reached by 31 October 2017.

This study has the potential to significantly inform programs aimed at the prevention of HIV MTCT in South Africa and to directly impact clinical and public health practices in low and middle-income countries relating to maternal-child health, especially relating to bacterial STIs.