Pilot of an intervention for Malawian pregnant women with HIV to improve depression, viral suppression and engagement of partners in HIV self-testing
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Date
2021-03-17
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Kamuzu University of Health Sciences
Abstract
Type of research study: This will be a mixed-methods pilot study employing both qualitative and quantitative data collection
approaches. Qualitative methods will be used during formative work to adapt an intervention to treat
depression and optimise adherence to HIV medication for the Malawian antenatal context.
Quantitative methods will be used within a Phase 2 exploratory pilot trial aimed at testing the
feasibility and acceptability of the integrated intervention, and feasibility of collecting clinical
outcome measures at baseline and post randomisation follow up to inform a future fully powered
cluster randomised trial.
The problem to be studied
Globally, 38 million people are living with HIV, with nearly 70% of these in sub-Saharan Africa. Policies
to improve access to antiretroviral therapy (ART) for the treatment of HIV have dramatically reduced
the rate of HIV related mortality in sub-Saharan Africa. This is because ART supresses the level of virus
in the blood which halts the virus’s ability to attack the immune system. The result is that people
living with HIV have a significantly reduced risk of transmitting the virus to sexual partners and from
mother to child. HIV infection remains one of the biggest killers globally. However, the benefits of
ART are reliant on daily adherence to the regimen.
Malawi has a successful programme for prevention of mother to child transmission of HIV based on
routine antenatal testing and provision of ART. However, 23% of women attending HIV antenatal care
are lost to care at one year. Depression is an important cause of poor adherence to medication for the
treatment of HIV and disengagement from HIV care. Depression is two to three times higher in people
living with HIV than in the general population, and common in pregnant and post-natal women in
Southern Africa. Symptoms of depression such as reduced concentration, memory, problem-solving
ability and motivation, adversely affect engagement with health care and adherence to medication.
Malawi's successful programme of antenatal testing presents an opportunity to engage their male
partners in HIV testing. Men are less likely than women to test for HIV and know their status. In
Malawi over 45% of HIV-positive women in stable relationships have an HIV-negative partner.
Without intervention, HIV-negative partners acquire HIV at up to 12% per year. Supporting women to
adhere optimally to their HIV medication to ensure their virus is well controlled reduces the risk of
transmission to zero. HIV self-testing, whereby an individual collects their own sample, conducts the
test and interprets their result increases coverage and frequency of testing. Partner-delivered self-test
kits, where woman distribute a test to their male partner, is becoming routine antenatal policy and
practice in high HIV prevalence settings including Malawi.
Study objectives
The aim of the proposed research is to finalise and test the feasibility and acceptability of an
intervention for pregnant women living with HIV and depression, to reduce depression and optimise
engagement in HIV care, and to increase uptake of HIV testing, prevention and care for their male
partners.Specific aims are:
The overall aim of the study is to test the feasibility and acceptability of an intervention for depression
in people living with HIV called TENDAI-Together among pregnant women living with HIV and
depression in Blantyre.
Specific objectives in the Formative Phase of our research are:
1. To translate and back-translate the existing draft TENDAI-Together intervention from English to
Chichewa, a main language used in Blantyre2. To use qualitative methods (in-depth interviews and focus groups discussions) and Theory of
Change in Malawi to learn from women, partners, and health staff about terminology for distress
and views about an intervention, to learn how to adapt the intervention and how to implement it
in antenatal clinics in Bangwe Health Centre
3. To review emerging evidence on ingredients of efficacious brief psychological interventions for
couples, so we can strengthen the content of the intervention, and add 1-2 sessions for the
partner or significant other
Aim 1: To finalise “Task-shifting to improve Depression and Adherence to HIV medication”
(TENDAI-Together), a task-shifted intervention to treat depression and optimize adherence to ART
for antenatal women living with HIV in Malawi.
4. Aim 2: To develop finalise an Short-Message Service (SMS) -based intervention for providing to
information on the correct use of HIV self-test kits and provide "U = U" "Undetectable =
Untransmutable" HIV messages education for targeting male partners of antenatal women living
with HIV.
5. To integrate knowledge gathered through 1-3 to inform adaption and a draft intervention
protocol for TENDAI-Together with the SMS-based HIV-self testing intervention.
6. Pilot test the intervention through a small case series to learn about training of interventionists
and to iteratively finalise the intervention.
Specific objectives in the Feasibility Phase of our research are:
7. To test the feasibility of clinic-based recruitment, through running an individually randomised
pilot trial, with 20 women in the Tendai-Together arm and 20 women receiving enhanced usual
care
8. To test the fidelity of Tendai Together intervention delivery within the health centre context in
Malawi
Through these objectives, we will be ready to apply for a future RCT to test the effectiveness and costeffectiveness
of TT, and we will be in a position to justify whether the future trial will be in Malawi
alone or multi-country.
Aim 3a: To integrate TENDAI-Together with the SMS-based HIV-self testing intervention
Aim 3b: To test feasibility and acceptability of the integrated intervention, and feasibility of collecting
clinical outcome measures at baseline and post randomisation follow up through a Phase 2
exploratory trial to inform a future fully powered RCT.
Methodology
Formative work will involve finalising the TENDAI Together intervention to be suitable for the
Malawian antenatal context will include formative work, comprising focus group discussions(FGD) and
in-depth interviews (IDI) with 30 key informants (pregnant women, male partners, families, and
health workers). This work will ensure that our final checklist of barriers to ART adherence includes
those of most relevance for the ANC context, and to gather views and approaches about bringing the
woman’s partner, or an alternative significant other, into two of the sessions, to provide education
about depression and to inform about the U=U message (using self-testing SMS platform) and the
benefits of both partners knowing their HIV status.
The Pilot Trial will recruit 40 women in the 2nd trimester and randomise them, 3:1 to the active
intervention or enhanced usual care. We will test the feasibility and acceptability of providing the TENDAI Together intervention with the self-testing SMS platform to allow the woman access to simple
care for depression, optimise her engagement in HIV care, and engage her partner with HIVST and
subsequent HIV care and prevention steps. We will also asses the feasibility of collecting clinical
outcome measures at baseline and at 6 months post randomisation follow up and 6 weeks postdelivery
for the infant, to inform a future fully powered RCT.
Expected findings and dissemination.
The expected findings for this study will include 1) Acceptability of the TENDAI Together intervention
to participants, intervention providers and clinic staff; Feasibility of methods for conducting a future
randomised controlled trial powered to determine the effectiveness of the stepped care Tendai
Together intervention for depressed pregnant women living with HIV on viral suppression,
depression, infant outcomes and serostatus of male partner at 12 months follow up; and 3) Feasibility
of collecting clinical outcome measures for depression, viral load, infant clinical outcomes and uptake
of HIV self-testing by male partner. Our aim to share our findings with scientists in the field, COMREC,
College of Medicine Library, research participants and Malawians who can influence local policy. We
plan to publish the findings of this study in peer-reviewed journals. Participants will be given written
feedback on the results of the trial. We plan to present findings from this study at scientific
conferences.
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Research Subject Categories::MEDICINE