Principal Investigator: Dr Tafireyi Marukutira, MD, PhD, MPH

Study Objectives:

Primary Objective:

To test the efficacy of single-dose nonavalent HPV vaccination to prevent incident persistent HPV 16/18/31/33/45/52/58 infection among women living with HIV who were vaccinated against HPV 16/18 before HIV diagnosis

Secondary Objectives:

1. Measure linkage to care, ART coverage, retention, and viral suppression (HIV care cascade) at a local program level before and after the migrant-inclusive HIV policy change using the Maipelo Clinic cohort.
2. Measure the impact of migrant-inclusive HIV policy changes at a country level, by using national HIV surveillance data to compare the HIV care cascade between migrants and citizens in Botswana over time.
3. Through mixed-methods approach, explore factors associated with variations in linkage and retention in care before and after the policy change.
4. Undertake epidemic and economic modelling, using data generated from objective 1 and 3, to determine:

1. the impact of the migrant-inclusive HIV policy changes introduced in 2019 on the overall epidemic, disease burden and prospects of achieving a 90% reduction in incidence in Botswana, and
2. the cost-effectiveness of the migrant-inclusive HIV policy changes.
3. Review HIV surveillance systems in Botswana and the Southern Africa region to identify optimum systems needed monitor progress towards HIV elimination.

Study Design:

This is a mixed methods study. A retrospective cohort study will be conducted at clinic level data to determine linkage, ART coverage, retention, and viral suppression (HIV care cascade) outcomes among migrants (Maipelo Clinic Cohort). The HIV care cascade will be compared pre and post migrant-inclusive HIV policy shift (before 2020 and 2020-2024)

Study population:

The primary study population for this study is a cohort of non-citizens/migrants living with HIV (MLHIV) who previously attended Maipelo Clinic until 2019/2020.

Sample size:

The retrospective cohort sample will be all 768 patients ever registered under Maipelo Clinic, with participant indicator data obtained from the Maipelo Clinic Database and the National HIV Database.

Estimated total number of PLHIV in Botswana will be extracted from Spectrum model (The most recent UNAIDS Spectrum (2021) estimates PLHIV at 364,437 and incidence rate at 0.27 (6,728 new infections). Programmatic data of all people living with HIV will be used for to crate the HIV care and treatment cascade analysis.

Study duration: 3 years

Sponsor: Burnet Institute through funding a Fellowship Program funded by the National Health and Medical Research Council (NHMRC), Australia.