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:
-
Prevalence of pregnancy;
-
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;
-
Engaging in transactional sex in the past six
months;
-
Two or more sexual partners in the past six
months;
-
HIV knowledge;
-
Financial literacy;
-
Participation in a savings group;
-
Opening a savings account;
-
Total amount of savings in past year;
-
Saving for education;
-
Caregiver providing youth money for savings;
and
-
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.