Background: Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART. Methods: This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standardof-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses.
Introduction
Although knowledge of HIV positivity is a necessary step towards engagement in HIV care, more than one quarter of HIV‐positive Malawians remain unaware of their HIV status. Testing the sexual partners, guardians and children of HIV‐positive persons (index case finding or ICF) is a promising way of identifying HIV‐positive persons unaware of their HIV status. ICF can be passive where the HIV‐positive individual (index) invites a partner (or contact) for HIV testing or active where a health provider assists the index with partner notification and offers HIV testing to the partner. Strategies to improve passive ICF have not been thoroughly studied. We describe the impact of a behavioural skills‐building training to enhance healthcare workers’ (HCWs) implementation of Malawi's passive ICF programme.
Methods
In June 2017, HCWs from 36 health facilities in Mangochi were oriented to Malawi's ICF programme and began implementation. In February and April 2018, a total of 573 HCWs from these facilities received further training from the Tingathe Programme. The training focused on eliciting more untested sexual contacts from indexes and better equipping indexes on issuing “family referral slips” to contacts. Monthly programmatic data were abstracted from clinical registers from October 2017 to July 2018. Monthly programmatic indicators were collected from the Index Case Testing Register and the HIV Counselling and Testing Register and were entered into a data set with one record per facility per month. T‐tests were used to compare the means of these indicators.
Results
During the ten‐month study period, there were 200 facility‐months observed before and 124 facility‐months observed after training. The mean number of indexes identified per facility‐month remained stable after training (pre = 18.9, post = 21.2, p = 0.74), but the mean number of sexual partners listed per facility‐month (pre = 6.3, post = 10.6, p < 0.001) increased. The mean number of contacts who received HIV testing (pre = 11.1, post = 24.8, p < 0.001) and the mean number of HIV‐positive contacts identified per facility‐month (pre = 1.3, post = 2.3, p < 0.001) also increased.
Conclusions
A brief behavioural skills‐building training impacted a range of meaningful outcomes, including identification of HIV‐positive individuals in a passive ICF programme. Such approaches could facilitate the identification of HIV‐positive persons unaware of their HIV status, a necessary step for engagement in HIV care.
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