Nested Studies
Tuberculosis prevention
and care
Among people living with HIV in sub-Saharan Africa, tuberculosis is the most common cause of mortality. Active tuberculosis is not diagnosed in up to 30% of those affected. Despite known benefits, tuberculosis preventive therapy is not used to its full potential.
In the VITAL intervention arm, the delivery of tuberculosis preventive therapy will be coordinated with that of HIV therapy and facilitated by automated reminders. Screening by automated phone calls replaces screening in clinic. We then compare uptake and completion of tuberculosis preventive therapy and the incidence of active tuberculosis between the control and the intervention arms.
Mental health study
Mental health comorbidities are frequent among people living with HIV and may influence clinical outcomes. However, very little data exists on common mental health disorders (CMDs) among people living with HIV in Lesotho.
The goals of this nested study are: 1) to evaluate the prevalence and longterm course of CMDs in adults living with HIV in Lesotho. 2) to establish the links between CMDs and clinical and virologic HIV treatment outcomes. 3) to validate a short assessment tool for CMDs that can be administered by lay people.
The ideal viral load threshold
Currently, WHO guidelines define virologic treatment failure at the threshold value of 1000 copies of HIV-1 RNA per mL of blood. It is, however, not clear if a lower threshold might be more appropriate. To respond to this question, in the VITAL study, a viral load result of 20-999 copies/mL will trigger a further viral load measurement after 3 months to assess the likelihood of spontaneous resuppression or viral load increase during this period. This will generate evidence to inform a potential revision of viral load thresholds in this setting.
Viral resistance survey
Currently, most countries in sub-Sahara Africa are transitioning first-line therapy from efavirenz- to dolutegravir-based ART. There are, however, first case reports of viral resistance to dolutregavir. Therefore, there is a need for clinical longitudinal monitoring and resistance testing. The VITAL trial offers ideal conditions for such longitudinal monitoring of treatment failure and emergence of resistance after the roll-out of dolutegravir in a real-life setting.
Cervical cancer screening coverage
Cervical cancer is the leading cause of cancer deaths among women in sub-Saharan Africa. Women living with HIV are four to five times more likely to suffer from cervical cancer. Because cervical cancer is preventable if abnormal cells are detected early, we will monitor how often women are screened and conduct a qualitative analysis of factors preventing clinics from screening.
