Huge increase in PrEP uptake when services offer choice, flexibility and injectable PrEP, African study shows

A programme in rural Kenya and Uganda that has already demonstrated that a dynamic, person-centred HIV prevention intervention results in substantial increases in the numbers of people covered by PrEP or PEP, has now shown the added benefits of offering a choice between PrEP pills and PrEP injections.

When services were offered in the usual way, a minority of people used oral PrEP or PEP. When services were optimised to provide choice and flexibility, uptake more than doubled. And in the latest stage of the randomised study – with the additional option of PrEP injections – 70% of people used some form of biomedical HIV prevention.

“Person-centred options and long-acting cabotegravir are needed to increase biomedical prevention coverage,” Dr Moses Kamya of Makerere University in Uganda told the Conference on Retroviruses and Opportunistic Infections (CROI 2024) in Denver this week.

As aidsmap reported from last year’s CROI, the researchers first conducted qualitative work to identify barriers to the uptake of HIV prevention and design their ‘dynamic choice prevention intervention’. This comprised:

• A choice of prevention product – people could switch between PrEP, PEP, condoms and nothing as their needs and preferences changed.
• A choice of service location – people could receive services from a clinic, over the phone, in their home or in another community setting. Nurses and community health workers could visit people in a convenient place, including away from their home if that addressed confidentiality concerns.
• A choice of ways to take an HIV test – self-testing or a rapid test done by a healthcare worker.
• People could receive up to three months’ of oral PrEP at a time.
• Starter packs of PEP were provided, giving people enough tablets for the first few days, with the rest of the course provided when needed.
• Clinicians could be reached by phone seven days a week to discuss starting PEP or PrEP, give advice and answer questions.
• Staff were trained to assess barriers to starting and sticking with PEP or PrEP, and to develop personalised plans in response to those barriers.
• Staff provided referrals to services addressing reproductive health, sexually transmitted infections, trauma and gender-based violence.

The intervention was compared to the care that is routinely available – referral to other health facilities to access prevention services.

The impact of the intervention was assessed by measuring biomedical HIV prevention coverage – the proportion of time that people said they were using PEP or PrEP during almost a year of follow-up. They also assessed biomedical HIV prevention coverage during periods ‘at risk’ – periods in which people reported sex with someone who was not known to be HIV negative, reported transactional sex or felt they were at risk.

In the first phase, presented at last year’s CROI, results were reported separately for the three different settings in which the intervention was provided. One was community health workers going door-to-door in villages: in the standard-of-care arm, PrEP or PEP was used for 0.5% of the time, rising to 28% of the time in the intervention arm. In antenatal clinics, prevention coverage was 29% in the standard-of-care arm, compared to 70% in the intervention arm. Finally, in outpatient departments at health facilities (used for a wide range of health needs in these rural areas), coverage was 18% and 48%, respectively.

Not satisfied with this level of coverage, the researchers extended the study, with injectable PrEP (cabotegravir) as an additional option, alongside oral PrEP, PEP and condoms. Although the dapivirine vaginal ring was not an option in this phase of the study, it will be in phase III.

The cabotegravir injections are every two months, without an oral lead-in. They must be provided at government clinics, so there is less choice of location with this option.

Findings

In the second phase of the study, outcomes were assessed in 984 HIV-negative people who were considered at risk of acquiring HIV. Half were randomly assigned to have access to the intervention; the other half received the standard of care. Results were reported for all three settings combined: community health workers going door-to-door, antenatal clinics and outpatient departments.

Almost three-quarters (73%) of enrolled participants were female and 70% were over the age of 25. More detailed demographic information was not presented.

In the standard-of-care arm, a form of biomedical HIV prevention was used just 13% of the time. This rose to 70% in those receiving the intervention. In terms of coverage during time at risk, this was 16% in the standard-of-care and 77% in the intervention arm. These results were broadly consistent between genders and between age groups.

In the intervention arm, over a quarter of participants used at least two different prevention options during the 48 week study. There were 53% of participants who used oral PrEP and 56% who used injectable PrEP for some of the time, while PEP was occasionally used (2%). Notably, of those who started injectable PrEP at the beginning of the study, 42% hadn’t been using any form of HIV prevention in the month before. Injectable PrEP is not simply replacing oral PrEP, noted Dr Kamya. “It’s expanding the pie,” he said.

The intervention did not just increase HIV prevention coverage, it cut HIV incidence to zero. In the standard-of-care arm, seven people seroconverted during the study (incidence of 1.8% per year), as well as one infant born to a participant who was not included in the incidence calculation. In the intervention arm, there were no seroconversions at all.

Dr Carole Camlin, a qualitative researcher working on the study, said that the discretion of injectable PrEP – as opposed to daily pills – was something participants particularly valued. They also appreciated the fact that the product was clearly different from the antiretroviral therapy that many other people in the community were taking.

Mitchell Warren of AVAC said that he and many other advocates and researchers had always argued for choice, but hadn’t had the evidence that it really made a difference in HIV specifically.

“This is the evidence we’ve all been waiting for,” he told aidsmap. “This is the first time in a community setting that we have scientific evidence that choice matters and choice works.”