Randomized Controlled Pilot Study of Antiretrovirals and a Behavioral Intervention for Persons With Acute HIV Infection: Opportunity for Interrupting Transmission

Abstract

Background: Persons with acute HIV infection (AHI) have heightened transmission risk. We evaluated potential transmission reduction using behavioral and biomedical interventions in a randomized controlled pilot study in Malawi.

Methods: Persons were randomized 1:2:2 to standard counseling (SC), 5-session behavioral intervention (BI), or behavioral intervention plus 12 weeks of antiretrovirals (ARVs; BIA). All were followed for 26-52 weeks and, regardless of arm, referred for treatment according to Malawi-ARV guidelines. Participants were asked to refer partners for testing.

Results: Among 46 persons (9 SC, 18 BI, 19 BIA), the average age was 28; 61% were male. The median viral load (VL) was 5.9 log copies/mL at enrollment. 67% (10/15) of BIA participants were suppressed (<1000 copies/mL) at week 12 vs 25% BI and 50% SC (P = .07). Although the mean number of reported condomless sexual acts in the past week decreased from baseline across all arms (1.5 vs 0.3 acts), 36% experienced incident sexually transmitted infection by 52 weeks (12% SC, 28% BI, 18% BIA). Forty-one percent (19/46) of participants referred partners (44% SC, 44% BI, 37% BIA); 15 of the partners were HIV-infected.

Conclusions: Diagnosis of AHI facilitates behavioral and biomedical risk reduction strategies during a high-transmission period that begins years before people are typically identified and started on ARVs. Sexually transmitted infection incidence in this cohort suggests ongoing risk behaviors, reinforcing the importance of early intervention with ARVs to reduce transmission. Early diagnosis coupled with standard AHI counseling and early ARV referral quickly suppresses viremia, may effectively change behavior, and could have tremendous public health benefit in reducing onward transmission.

Keywords: HIV; Malawi; acute HIV infection; motivational interviewing; transmission.

Figure 1.

^{Participant screening, enrollment, and allocation to study arm. a}Blood was not collected for 12 consenting participants; another 97 participants had insufficient volume for testing or the specimen clotted before testing. ^bFalse-negative antibody test from screening was confirmed on laboratory retest. Abbreviations: AHI, acute HIV infection; BI, behavioral intervention; BIA, behavioral intervention plus treatment; HTC, HIV testing and counseling; SC, standard counseling; STI, sexually transmitted infection.

Figure 2.

Mean number of condomless sex acts over the previous month (left) or previous week (right) over the course of the study, by study arm. Abbreviations: BI, behavioral intervention; BIA, behavioral intervention plus treatment; SC, standard counseling.

Figure 3.

Log10 viral load by study arm. Median, mean, and individual viral loads are shown. Viral load for one elite suppressor in the BIA arm is also shown. Abbreviations: BI, behavioral intervention; BIA, behavioral intervention plus treatment; SC, standard counselling; VL, viral load.