Pilot of an intervention for Malawian pregnant women with HIV to improve depression, viral suppression and engagement of partners in HIV self-testing
| dc.contributor.advisor | ||
| dc.contributor.author | Abas, Melanie | |
| dc.date.accessioned | 2021-11-24T11:14:00Z | |
| dc.date.available | 2021-11-24T11:14:00Z | |
| dc.date.issued | 2021-03-17 | |
| dc.description.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. | en_US |
| dc.description.sponsorship | Kamuzu University of Health Sciences | en_US |
| dc.identifier.uri | http://rscarchive.kuhes.ac.mw/handle/20.500.12988/362 | |
| dc.language.iso | en | en_US |
| dc.publisher | Kamuzu University of Health Sciences | en_US |
| dc.relation.ispartofseries | Ethics Protocol;P.11/20/3183 | |
| dc.subject | Research Subject Categories::MEDICINE | en_US |
| dc.title | Pilot of an intervention for Malawian pregnant women with HIV to improve depression, viral suppression and engagement of partners in HIV self-testing | en_US |
| dc.type | Plan or blueprint | en_US |