Cluster randomized intervention trial to evaluate the impact of the 'opt-out' versus 'opt-in' strategy on the uptake of HIV counseling and testing of tuberculosis patients in the Province of the Eastern Cape, South Africa.

摘要

Background. Tuberculosis patients have a high likelihood of HIV infection and can benefit from preventive and clinical interventions, but are often not tested. The current standard of care is that TB patients should be offered HIV counseling and testing; the patient must agree to be counseled, to 'opt-in'. We conducted a cluster-randomized trial comparing the Opt-out Strategy to the standard of care. The Opt-out Strategy provides routine HIV counseling and testing to all new TB patients unless they refuse, 'opt -out'. The primary endpoints were the proportion of new TB patients receiving HIV counseling and testing. Secondary outcomes included the proportion of patients with positive HIV test results and the proportion prescribed cotrimoxazole and/or referred to HIV care.; Methods. We randomized 20 TB clinics in the Nelson Mandela Metropolitan Municipality of the Eastern Cape to the Opt-out Strategy or the standard of care. The TB nurses in all study clinics received HIV counseling and testing training from the municipal health department and training in the use of an HIV Counseling and Testing Register introduced by the study team. The TB nurses in the 10 clinics allocated to the intervention received an additional 2-day training in the Opt-out Strategy.; Results. Data were collected on 754 eligible adult (≥18 years) TB cases covering a 10-week period. A mean of 23% versus 8.7% of the TB cases in the intervention versus control clinics received HIV counseling (t-test, p = 0.03), and 22.4% versus 7.7% received HIV testing (t-test p = 0.03). There were no significant differences in the proportion of patients with a positive HIV test result (36.9% vs. 42.6%), cotrimoxazole prophylaxis (29.6% vs. 33.3%) and referral for HIV care (36.9% vs. 16.7%) between study arms.; Conclusion. Use of the Opt-out Strategy resulted in a significant improvement in the proportion of TB cases counseled and tested for HIV, although uptake overall was still low. Pragmatic, cluster-randomized studies carried out in the public sector can inform policy decisions.