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21st International AIDS Conference (AIDS 2016)

News

PROMISE Results Support WHO Recommendations for Pregnant and Breastfeeding Women: More Needs to Be Done to Improve ART Acceptability and Adherence

August 4, 2016

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Low Acceptance of ART Among Women With Higher CD4 Counts: They Need More Time to Consider

Following the START results, in June 2015, all women not receiving ART at that time were recommended to start for their own health.

In a second oral late breaker, Lynda Stranix-Chibanda showed PROMISE participants' response to these recommendations and their reasons to accept of decline ART.8

The study used a mixed methods approach to collect responses from participants receiving the START information. Study staff contacted participants to return to the clinic and gave START results. This was done using a structured script, the language was chosen by the participant and the staff assessed comprehension. Information included that about the trial aims, study location and results.

Participants also attended a counselling session to discuss the implication of START for them as individuals. Those not receiving ART discussed the offer of starting with the study staff and decided whether or not to accept during that session.

Women selected their primary reason for accepting or rejecting the offer from a set of options. The results were recorded and categorised by the study staff.

All 1483 women not on ART were advised to start: 984 women (66%) accepted the offer but 499 (34%) declined. Acceptance rates varied by country, quite broadly, with a mean of 66% (Brazil) and range of 100% (Peru) to 37% (Tanzania). Reasons for accepting or declining ART after initial counselling session are shown in table 2.


Table 2: Reasons for Accepting or Declining ART in PROMISE
Reason 1077BF/FF 1077HS
For Accepting ART
Concerned about health 46% 43%
Understands treatment is now recommended 35% 36%
Concerned about CD4 count 16% 13%
Other reason 2% 7%
For Declining ART
Wants more time to consider 44% 33%
Feels well/knows CD4 count is high 13% 28%
Concerned about HIV disclosure 9% 3%
Concerned about commitment to life-long ART 9% 7%
Concerned about potential side effects 8% 8%
Other reason 7% 14%
Knows not indicated in current guidelines 6% 0%
Too busy with childcare or other responsibilities 2% 5%
Concerned about adherence 1% 5%


Dr Stranix-Chibanda explained that a number of women were not willing to start ART after a single counselling session. This was despite exposure to considerable ART education and HIV monitoring within a well-resourced trial setting.

Women particularly needed time to consider starting ART and the researchers noted that the women continued to be offered ART through to study exit and the proportion remaining off ART decreases with each visit.


Breastfeeding

Finally, data were shown from the PROMISE 1077BF study, designed to compare transmission rates with maternal ART vs infant nevirapine (NVP) during extended breast feeding until 18 months post-delivery (the first randomised trial to do so). Taha Taha and colleagues showed these findings in a late breaker poster.

This postpartum component of PROMISE was conducted in 14 sites in: Indian, Malawi, South Africa, Tanzania, Uganda, Zambia and Zimbabwe.

The study enrolled 2431 mother and their HIV uninfected infants between June 2011 and October 2014. They were randomised at 6-14 days postpartum to maternal ART plus six weeks of daily infant NVP (n=1220) or daily infant NVP (n=1211). Women were asymptomatic with a median CD4 count 686 cells/mm3 and 97% WHO stage I). They were a median age of 26 years. Infants had a median gestational age of 39 weeks and birthweight of 2.9 kg.

Baseline characteristics were similar across study arms. The median duration of breastfeeding was 15 months was also similar across study arms (p=0.85).

Rates of HIV transmission during breastfeeding were very low and did not differ significantly between arms at 12 months postpartum these rates were 0.5% with maternal ART and 0.6% with infant nevirapine. Rates of infant survival were high (98.9%) and did not differ significantly between arms (p=0.72).


References

All references are to the programme and abstracts of the 21st International AIDS Conference, Durban, South Africa, 18-22 July, 2016 (AIDS2016), unless otherwise stated.

  1. Clayden P. Three drug regimen superior for preventing vertical transmission in the PROMISE study. HTB. 29 January 2015.
    http://i-base.info/htb/27716
  2. Fowler MG et al. PROMISE: Efficacy and safety of 2 strategies to prevent perinatal HIV transmission. CROI 2015. 2015 Conference on Retroviruses and Opportunistic Infections (CROI 2015), 23-26 February 2015, Seattle. Oral abstract 31LB.
    www.croiconference.org/sessions/promise-efficacy-and-safety-2-strategies-prevent-perinatal-hiv-transmission
  3. Clayden P. Three drug ART best for preventing vertical transmission to infants: results from the PROMISE study. HTB. 24 March 2015.
    http://i-base.info/htb/27907
  4. National Institutes of Health press release. NIH-sponsored study identifies superior drug regimen for preventing mother-to-child HIV transmission. 17 November 2014.
    www.nih.gov/news/health/nov2014/niaid-17.htm
  5. The INSIGHT START study group. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med 2015; 373:795-80. (27 August 2015).
    www.nejm.org/toc/nejm/373/9
  6. WHO. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations 2016 update. July 2016.
    www.who.int/hiv/pub/guidelines/keypopulations-2016/en
  7. Currier J et al. Randomised trial of stopping or continuing ART among post-partum women with pre-ART CD4 >400 cells/mm (PROMISE 1077HS). AIDS2016. Oral abstract THAB0103LB.
    http://programme.aids2016.org/Abstract/Abstract/10082 (abstract)
  8. Stranix-Chibanda L et al. Low acceptance of early antiretroviral therapy (ART) among post-partum women enrolled in IMPAACT PROMISE studies across the globe. AIDS2016. Oral abstract THAB0106LB.
    http://programme.aids2016.org/Abstract/Abstract/10331 (abstract)
  9. Taha TE et al. Comparing maternal triple antiretrovirals (mART) and infant nevirapine (iNVP) prophylaxis for the prevention of mother to child transmission (MTCT) of HIV during breastfeeding (BF). AIDS2016. Poster abstract LBPE013.
    http://programme.aids2016.org/Abstract/Abstract/10209
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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
 


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