1. Jim K. Aizire, MD, MHS, PhD Johns Hopkins University
PEPFAR PROMOTE STUDY
High Frequency of Unintended Pregnancy and Predictors of Contraceptive Choice among HIV-infected African Women on Lifelong ART  
J. Aizire , N. Yende , T. Nematadzira , M.E. Nyati , S. Dadabhai , L. Chinula , C. Nakaye , M. Naidoo , M.G. Fowler , T. Taha , US-PEPFAR PROMOTE Cohort  
Jim K. Aizire, MD, MHS, PhD Johns Hopkins University
26 July 2018

2. Background
Reproductive health burden in sub-Saharan Africa
Home to more than 90% of the reproductive health needs globally
Women of reproductive age constitute more than 60% of the HIV/AIDS burden
Several countries have more than 60% unmet need for modern family planning methods
More than 85% of unintended pregnancies are attributed to non-use of an effective family planning (EFP) method (injectable, oral, intra-uterine contraceptive device (IUCD), or Norplant).
Most commonly reported reasons for not using EFP include infrequent sex and safety/side-effects. Others include postpartum/breastfeeding, opposition by the partner, as well as access related reasons.
Department of Economic and Social Affairs PDUN. Trends in contraceptive use worldwide Contraception. 2015:
Darroch JE et al, Lancet 2013; Darroch JE et al, Responding to Women’s Needs. New York: Guttmacher Institute; 2011
26 July 2018

3. HIV infected women on ART
Study design
HIV infected women on ART
Standardized procedures across 8 sites in 4 countries (Malawi, Uganda, South Africa and Zimbabwe)
Methods
Wilcoxon Rank-Sum tests (continuous variables)
Poisson regression (with robust variance) to estimate measures of association
Chi-square test (categorical variables)
SEP 2015
DEC 2016
JUN 2017
PROMISE RCT
GAP
PEPFAR PROMOTE STUDY
2011
2020
2015
2016
2017
2018
2019
2020
2021
Baseline assessments
Follow-up assessments
Socio-demographic data
Clinical data (reproductive health)
Lab data plus stored samples
26 July 2018

4. High reports of unintended pregnancy (at last conception)
Variations by site (P <0.001)
(n=249)
(n=271)
(N=1,985)
26 July 2018

5. Contraceptive use by country
Variations by site (P <0.001)
26 July 2018

6. Use of Effective Family Planning (EFP) and Long Acting Reversible Contraceptive (LARC) methods
EFP methods (injectable, oral, intra-uterine device (IUD), implant, or tubal-ligation).1
LARC methods (implants or IUD) are the most effective, and suitable for women who report infrequent sex, or hormonal side-effects.2
P =<0.001
Department of Economic and Social Affairs PDUN. Trends in contraceptive use worldwide Contraception. 2015:
Darroch JE et al, Lancet 2013; Darroch JE et al, Responding to Women’s Needs. New York: Guttmacher Institute; 2011
26 July 2018

7. Baseline characteristics (by reported EFP use at study entry)
Demographic and socioeconomic factors
Characteristic
Overall (N=1,295)
EFP use (n=1,054)
No EFP use (n=241)
P value
Maternal-age (years), median [IQR]
31 [28-35]
30 [26-35]
0.077
Married/regular partner, n (%)
1,140 (88.0%)
930 (88.2%)
210 (87.1%)
0.936
Unintended pregnancy, n (%)
662 (51.2%)
560 (53.2%)
102 (42.5%)
0.01
Desire another children, n (%)
490 (37.9%)
369 (35.0%)
121 (50.4%)
<0.001
No sex in the last 3 months, n (%)
126 (9.7%)
120 (11.4%)
6 (2.5%)
Clinic travel time ≥ 1 hour (yes), n (%)
365 (28.2%)
284 (26.9%)
81 (33.8%)
0.588
Education (completed primary), n(%)
1,007 (77.8%)
818 (77.6%)
189 (78.4%)
0.029
Unemployed/housewife, n (%)
588 (45.5%)
477 (45.3%)
111 (46.1%)
0.531
Electricity in household, n(%)
894 (69.0%)
723 (68.6%)
171 (71.0%)
0.173
Currently on ART, n (%)
1,265 (97.7%)
1,030 (97.7%)
235 (97.5%)
0.844
Viral load (>1,000 copies/ml), n (%)
112 (8.9%)
99 (9.6%)
13 (5.7%)
Baseline characteristics were homogeneous across LARC groups except:
Unemployed women were less likely to report LARC use (p = 0.008)
ART users less likely to report LARC use (p=0.001)
Viral load (>1000 copies/ml) were less like to report LARC use (p=0.003)
26 July 2018

8. Correlates of EFP and LARC use at PROMOTE study baseline
EFP use
LARC use
Adjusted
RR (95% CI)
P value
Unintended pregnancy
1.05 ( )
 0.086
1.18 ( )
0.174
Desire another child
0.92 ( )
0.017
1.05 ( )
0.703
No sex in last 3 months
0.81 ( )
<0.001
0.90 ( )
0.582
Married
1.10 ( )
0.064
0.86 ( )
0.365
Not completed primary school
0.92 ( )
0.03
0.83 ( )
0.202
Housewife/ no formal income
0.94 ( )
0.066
0.66 ( )
0.011
Electricity in household, yes
0.97 ( )
0.419
1.33 ( )
0.04
Clinic travel time ≥ 1 hour
0.401
0.90 ( )
0.486
Viral load, ≤1000 copies/ml
1.10 ( )
0.013
1.64 ( )
0.002
Modified Poisson regression (robust variance estimator); adjusted for age and country
26 July 2018

9. Future plans/ policy implications
Conclusion
Future plans/ policy implications
Planned PROMOTE cohort analyses
Incidence and correlates of unintended pregnancy through 18 months follow-up
Interactions between ART (efavirenz) and hormonal contraceptives and risk of unintended pregnancy (quantitative measures of ART and exogenous hormonal levels on stored samples)
Policy considerations for HIV infected women on ART
Risk of neural tube defects with dolutegravir
In this large multinational cohort of HIV infected African women on life-long ART we observed the following at baseline:
High prevalence of reported unintended pregnancy (at last conception)
About 20% women reported use of non-EFP methods, and only about 20% reported use of LARC methods. There were site variations, with a trend towards one predominant method at site level.
Unintended pregnancy at last conception was NOT associated with use of EFP or LARC methods.
Tsepamo study, May 2018, and WHO rapid memo
26 July 2018

10. Acknowledgements
The PROMOTE protocol team gratefully acknowledges the dedication and commitment of the more than 1,900 STUDY mothers
Sponsors: US PEPFAR (Nareen Abboud)
Protocol Chairs : Taha Taha, MG Fowler
Statistical and Data Management Center:
N, Yende, P Radebe, S Brummel, A Jeewa, N Hua
Site PROMOTE Investigators:
Blantyre, Malawi B Makanani
Lilongwe, Malawi L Chinula
Kampala, Uganda M Owor
Harare, Zimbabwe T Chipato
Soweto, South Africa ME Nyati
Durban, South Africa S Hanley

11. Baseline characteristics (ART regimens used at study entry)
No reported use of dolutegravir
26 July 2018

12. Correlates of EFP and LARC use at PROMOTE study baseline
EFP use
LARC use
Adjusted
RR (95% CI)
P value
Unintended pregnancy
1.05 ( )
 0.086
1.18 ( )
0.174
Desire another child
0.92 ( )
0.017
1.05 ( )
0.703
No sex in last 3 months
0.81 ( )
<0.001
0.90 ( )
0.582
Married
1.10 ( )
0.064
0.86 ( )
0.365
Not completed primary school
0.92 ( )
0.03
0.83 ( )
0.202
Housewife/ no formal income
0.94 ( )
0.066
0.66 ( )
0.011
Electricity in household, yes
0.97 ( )
0.419
1.33 ( )
0.04
Clinic travel time ≥ 1 hour
0.401
0.90 ( )
0.486
Viral load, ≤1000 copies/ml
1.10 ( )
0.013
1.64 ( )
0.002
Modified Poisson regression (robust variance estimator); adjusted for age and country
26 July 2018